News Article | November 16, 2016
If you manufacture high value product, you should be concerned with cleanliness, contamination control, and reliability. Two new documents that are directed at the medical device community provide sensible, practical guidance for all manufacturers of high value product. ASTM standard F3127-16: “Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices” is a gold mine of useful approaches and procedures. While the scope of this newly published standard is limited to cleaning of single use medical devices during manufacture and prior to use, the document draws on knowledge from other high-value product including semiconductors, electronics, cleaning for oxygen environments, and aerospace. The comprehensive standard is a guidance document for developing and validating a cleaning process, not a step-by-step recipe. The detailed validation flowchart in the guidance document is a useful, adaptable resource. The approach encompasses the concept of “validation readiness” through process understanding and documentation. It emphasizes the importance of cleaning throughout the supply chain as opposed to depending on final cleaning. It also includes the concept that validation is not a one-time only event and instead alludes to ongoing validation and monitoring.1 The first decision point on the flowchart poses the question, “Is the device designed for cleanability?” This brings up our all-important issue of establishing communication between designers, assemblers, and quality managers. It is essential to achieve appropriate product safety and performance. We sometimes quip that the first step is to tie design engineers to a chair with duct tape and force them to try to assemble and clean a prototype of their proposed design. In actuality, a kinder, more productive approach to implementing the guidance document is to set up a manufacturing team early on in product development and to include design engineers. The phrase “regulatory issues” tends to evoke the FDA. However, there are other regulatory issues — worker safety and environmental compliance. The ASTM guide does not specifically address the mechanism of achieving safety and environmental compliance. Attendees at a recent program for critical cleaning in the life-sciences expressed frustration over pronouncements about allowable chemicals and activities voiced by their safety and environmental groups. Rather than avoidance, exclusion, or analogous use of duct tape, we suggest that safety and environmental professionals also be involved in product development. With the correct engineering controls, it is usually possible to implement cleaning processes that meet safety and environmental requirements while assuring product/patient safety. The guide is comprehensive. Other sections include approaches and procedures for determining the scope of contaminating materials, risk analysis, and developing limits of acceptable residue. Considerable detail is provided regarding both specific and non-specific analytical methods, in approaches to selecting the appropriate techniques for the application. The guide also recognizes the importance of sampling techniques. Additive manufacturing (3D printing) is entering the mainstream of manufacturing. The FDA has responded with an encompassing, interactive approach. In May 2016, the FDA Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued a draft guidance document.2 The FDA hosted a workshop in 2014 to explore issues that might arise with medical devices manufactured by additive manufacturing.3 The 2016 draft guidance document builds on ideas and concerns presented at this workshop. What are some potential issues for cleaning and contamination control? Design for cleanability is an even greater concern with additive manufacturing. Additive manufacturing enables the design of complex shaped devices. Devices could be designed to contain inner recesses that are difficult to access. Cleaning and/or rinsing fluids need to access surfaces and be removed from those surfaces in order to have adequate cleaning function. Validation of both cleaning and sterilization requires access to these surfaces to verify that the cleaning or sterilization process has occurred. The order of manufacturing can be different for additive manufacturing than for traditional. Consider a bone replacement device that contains an external porous region to enable biological attachment (osseointegration) to living bone. A traditional technique might begin with machining, followed by cleaning to remove machining fluids, followed by coating with a porous layer. In contrast, with 3D printing, the porous layer might be fabricated as part of the initial build. Any post-printing machining and cleaning would be complicated by the presence of the porous layer. On primary strength of additive manufacturing, especially for medical devices, is that the technology enables an economically feasible approach to “one-offs.” Patient-specific devices raise the variations in dimensions and shapes. This in turn raises the issue of cleanability and of cleaning validation. Still more contamination and cleaning issues can occur due to one of the primary strengths of the additive approach, the ability to economically fabricate patient specific devices. Variations in dimensions and shapes can complicate both cleaning and cleaning validation. Industry standards and guides will continue to be developed or adapted in response to new technologies like additive manufacturing. In May, the ASTM F04 Committee on Medical and Surgical Materials and Devices held a workshop on Additive Manufacturing for Medical Applications4 in order to explore the need for new or revised ASTM standards. FDA CDRH personnel helped to plan and conduct the workshop. In our own view, additive manufacturing may not require an entirely new set of industry standards but rather a mindfulness of which standards might need to be modified to meet new challenges. 2. FDA draft document, “Technical Considerations for Additive Manufactured Devices; Draft Guidance for Industry and Food and Drug Administration Staff.”
News Article | November 14, 2016
Led by former senior FDA official Casper Uldriks, ComplianceOnline’s on-demand seminar on FDA recalls returns to California in 2017. The two-day training program will address recall regulations, recall classification, and FDA’s recall database. This seminar will help you understand FDA's recall policy, how to establish a roadmap for conducting recalls and manage possible FDA enforcement actions. Attendees will take away practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up. This in-person training will assist recall managers, quality assurance managers, regulatory affairs directors, and risk and product liability managers, manufacturers’ sales and marketing managers, own label distributors and others within an organization. The 2016 ComplianceOnline food recall seminar participation from various healthcare and pharma organizations, such as Philips Healthcare, Mevion Medical Systems, Inc., Abbott Vascular, Edwards Lifesciences, Takeda Pharmaceutical Company Ltd, GSK Vaccines and others, have made the event an industry platform to reckon with. Seminar instructor Casper Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for CDRH. He developed enforcement actions and participated in the implementation of new statutory requirements. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. For more information or to register for the seminar, please click here. Dates: Thursday, February 9, 2017 (8.30 AM- 4.30 PM) and Friday, February 10, 2017 (8.30 AM- 4.30 PM) Location: San Jose, CA Registration Cost: $1,899.00 per registration Early bird discounts: For discounts on early registrations, please click here. Register by phone: Please call our customer service specialists at +1-888-717-2436 or email to customercare(at)complianceonline.com For more information on ComplianceOnline or to browse through our trainings, please visit our website. ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 35,000 professionals from 9,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (http://www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations. For more information please contact:
News Article | November 15, 2016
The Food & Drug Administration (FDA) has tapped the American Medical Informatics Association (AMIA) to be part of a select group of technical advisors, officials announced at the AMIA 2016 Annual Symposium. Known as the Network of Experts, AMIA will provide rapid access to informatics expertise when needed by FDA officials within the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER). “This further validates AMIA as a trusted source of evidence-based informatics expertise,” said AMIA Board Chair and Medical Director of IT Services at the University of Washington’s UW Medicine, Thomas H. Payne, MD, FACP, FACMI. “We are proud to be part of FDA’s Network of Experts, and look forward to helping the FDA understand how informatics can be leveraged to address emerging medical devices and novel pharmaceuticals.” The Network of Experts is a vetted network of partner organizations and their member scientists, clinicians and engineers who can provide CDRH and CDER staff with access to expertise to supplement existing knowledge within the Centers. In a description of the Network, FDA notes that despite the tremendous internal cadre of scientific expertise within CDRH and CDER, it is unrealistic to expect staff to encompass all of the applicable expertise and experience necessary to fulfill its mission, given the rapidly growing variety and complexity of medical devices and pharmaceuticals. This is particularly true when it comes to new and emerging fields of science and pioneering technologies. In these areas, it is often necessary for staff to gain further scientific understanding from sources outside of the federal government. The Network of Experts facilitates this exchange. “AMIA stands alone in this distinction among peer associations,” said AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACP, FACMI. “The Network of Experts provides AMIA members a unique opportunity to improve health and healthcare on a national scale.” 2017 will be an important year for the FDA as medical device and prescription drug user fee agreements are debated and authorized by Congress. These agreements outline how FDA will spend billions of dollars in user fees collected from medical device and pharmaceutical companies to review products and drugs. Among the commitments made by FDA to industry are plans to use “real-world evidence,” or RWE, to evaluate the safety and effectiveness of devices and drugs; the use of advanced simulations for clinical trials and “model-informed drug development,” or MIDD; and creation of a Digital Health unit inside CDRH to review Software-as-a-Medical Device and Software-inside-a-Medical Device, known as SaMD and SiMD, respectively. FDA officials have also discussed their vision for a National Evaluation System for health Technology, or NEST, which will include functional links across a range of systems and federal agencies, developed to capitalize on existing digital information collected in the course of health care delivery, such as electronic health records, insurance claims, and data housed in clinical registries. “As we look to the horizon, the impact that informatics can have in helping FDA balance the need to facilitate innovation while protecting public health and safety is enormous,” said AMIA Vice President for Public Policy Jeffery Smith, MPP. “During our 2016 AMIA Policy Invitational, FDA Commissioner Califf called informatics ‘a gateway to bring the two together, to facilitate innovation and regulation at the same time.’ We agree, and our members stand ready to assist FDA in this mission.” AMIA’s Annual Symposium is the premier educational event in the field. The symposium presents leading-edge scientific research on biomedical and health informatics and over 100 scientific sessions. The Symposium presents work from across the spectrum of the informatics field -- translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics and public health informatics. AMIA, the leading professional association for informatics professionals, is the center of action for 5,200 informatics professionals from more than 65 countries. As the voice of the nation’s top biomedical and health informatics professionals, AMIA and its members play a leading role in assessing the effect of health innovations on health policy, and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health.
News Article | February 17, 2017
Driving a Culture of Change for Devicemakers Sponsored by Axendia **FDAnews Free Webinar** March 1, 2017 — 1:30 p.m. – 2:30 p.m. ET http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers Are manufacturers looking to reduce their regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability? Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product. How are the FDA and industry finding common ground creating a culture of quality? How is the CfQ creating a competitive marketplace for device quality? What are the market and regulatory incentives for device manufacturers? Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco Vicenty — Mechanical Engineer, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient. Register today and see how innovators are showing the industry that taking proactive approaches to quality can have significant business advantages. This webinar is made possible by PTC and Kalypso. Meet the Presenters: CAPT Sean Boyd, Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance: CAPT Sean M. Boyd serves as the Deputy Director for Regulatory Affairs in the Office of Compliance at FDA’s Center for Devices and Radiological Health (CDRH). In this capacity he is responsible for managing the Center’s quality initiatives, as well as regulatory compliance and enforcement programs for the medical device industry. He has been responsible for all aspects of medical device premarket, postmarket and compliance activities and, prior to joining the Office of Compliance in 2015, led and transformed many aspects of CDRH’s electronic product radiation control program. He is an expert in FDA’s requirements for a variety of consumer, commercial and industrial electronic products, as well as radiation-emitting medical devices. Daniel R. Matlis, President, Axendia: Daniel R. Matlis is Founder and President of Axendia, an analyst firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory matters. Dan has over 25 years of experience in the Industry spanning the entire value chain. He is an active member in FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA. Francisco (Cisco) Vicenty,Mechanical Engineer, US Food And Drug Administration: Cisco Vicenty is a Mechanical Engineer at US Food And Drug Administration. He is also currently the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients in order to increase focus on the quality and performance of medical devices. Webinar Details: Driving a Culture of Change for Devicemakers Sponsored by Axendia **FDAnews Free Webinar** March 1, 2017 — 1:30 p.m. – 2:30 p.m. ET http://info.fdanews.com/driving-a-culture-of-change-for-devicemakers About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
News Article | November 9, 2016
Inmedix, the leader in heart rate variability (HRV) application as an informative diagnostic tool in autoimmune disease, today announced that CEO & Co-founder, Andrew J. Holman, MD, will co-chair the ACR study group “Autonomic Neuroregulation of Autoimmune Disease” with Paul-Peter Tak, MD, PhD, Chief Immunology Officer & Senior Vice President R&D Pipeline at GlaxoSmithKline (GSK), during ACR/ARHP Annual Meeting 2016, being held November 11-16, 2016 at Walter E. Washington Convention Center, Washington DC. Also, speaking will be Carolina Kagan, MSc, regulatory scientist, reviewing pre- and post-market applications in the FDA's Center for Devices and Radiological Health (CDRH), the Office of in Vitro Diagnostics and Radiological Health (OIR) and Division of Immunology and Hematology Devices (DIHD). This 2016 study group follows the first-of-its-kind ACR study group in 2015 to examine how the brain regulates the immune system to affect rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and other autoimmune diseases. Innovative applications of this area of research will be discussed by the speakers and audience to develop better treatments, prediction and prevention of autoimmune diseases. Stress, controlled in the brain by the autonomic nervous system (ANS), appears to intensify RA and SLE flares to provide a new metric to more comprehensively understand how the disease is expressed in individual patients. Understanding how this component of the brain differs from person to person may be an important expansion in the concept of personalized, precision medicine. While genomics also contributes, the ANS may be more immediately actionable to mitigate its adverse effect on immune-mediated disease activity. It is hypothesized that this concept offers a potentially new way to address immune-mediated disease, especially autoimmune disease. “The ANS controls fight-or-flight stress responses which affect immune function,” says Andrew J. Holman, MD, Inmedix CEO, Associate Professor of Medicine at the University of Washington and rheumatologist. “While necessary for survival, its activation in the setting of an autoimmune disease is akin to injecting oxygen into a flame. We all hope for a magic bullet to neutralize the cause of RA, SLE and other autoimmune diseases but until that is discovered, awareness of how the brain adversely affects these diseases may offer a promising path in the near-term to further reduce the disease burden borne by our patients.” About Inmedix, LLC Seattle-based biotech Inmedix is committed to engaging in world class research to discover innovative solutions for pressing healthcare needs related to the autonomic nervous system (ANS). Inmedix’s ANS Neuroscan is the leading heart rate variability (HRV) application as an informative diagnostic tool in autoimmune disease, beginning with U.S. patients with rheumatoid arthritis (RA). The company’s science and technology raises therapeutic outcomes and retention so that patients no longer need to cycle through failure of one biologic after another. Visit http://www.inmedix.com
News Article | December 20, 2016
November Research Group, LLC, a global leader in the delivery of product vigilance software to leading biopharmaceutical and medical device manufacturers and regulators, is proud to announce that the company’s PRIMO product vigilance solution has been selected as the new product vigilance software solution for the United States Food and Drug Administration’s (FDA) Center for Food Safety and Nutrition (CFSAN). Mackson Consulting, a Woman Owned Small Business (WOSB) and strategic partner of November Research Group, is the prime contractor for the CFSAN project. Mackson Consulting has broad industry expertise, as well as extensive experience collaborating with the FDA providing award winning IT solutions and professional services. “We chose to propose PRIMO as it was the clear industry leader in Commercial off the Shelf (COTS) solutions in the market, that could meet the review and analysis requirements of the FDA,” stated Mary Biear, President of Mackson Consulting. CFSAN joins the FDA’s Center for Devices and Radiological Health (CDRH) in selecting PRIMO to replace their legacy adverse event systems with a solution geared toward the new era of proactive risk management. CFSAN’s responsibilities span the food and cosmetic industries, which includes the labeling of dietary supplements and food ingredients, post market surveillance and compliance of the food industry, and the safety of cosmetic ingredients. Unlike other commercial AE systems, PRIMO leverages a contemporary architecture to deliver a comprehensive risk management platform built to address the complexity of the challenges faced by manufacturers and regulators. PRIMO provides automation of routine activities while delivering superior analytics and insights. “While PRIMO brings a contemporary solution to the market, it was Mackson’s deep understanding of the CFSAN analysis and case management requirements and their stellar reputation that drove our decision to join their team,” said Tim Howard, President of November Research. November Research Group is a Berkeley, CA based software development company dedicated to delivering commercial product vigilance products for the risk management era. The core team of software developers and quality assurance engineers have been developing software in this domain for over 20 years. They have lead and participated in the development of the most adopted software solutions in this space, including EventNet/Oracle AERS, Relsys/Oracle Argus, and PRIMO. The PRIMO product vigilance platform is positioned to address one or all of the daunting regulatory challenges facing life science groups to provide a Part 11 Compliant solution to inbound email, streamline case intake and triage, deploy mobile and portal AE/PC intake, manage global partner and regulatory submission commitments, and provide medical user access to pharmacovigilance data using powerful queries, all while leveraging an open architecture that embraces integration with emerging cognitive computing technologies. Mackson Consulting LLC, is a Women Owned Small Business (WOSB) delivering IT services to the commercial and public sector markets, with a strong track record delivering on health information technology (HIT) modernization efforts. With a focus on systems engineering modernization and data management solutions, Mackson has been successful in the delivery of health modernization efforts including, but not limited to clinical trials data management and adverse events. Mackson received three separate and distinct industry honors in 2015 including the ACT/IAC 2015 Mobile Technology Award for Best Business investment of the year and multiple awards for innovative health modernization efforts. Mackson continues to lead the industry with expertise in federal health and professional services support.
News Article | February 21, 2017
Fonon Corporation today announced the release of Flexion™ technology to be incorporated in the CleanTech™ product line. Marketed under the Laser Photonics™ brand, CleanTech laser products are used for surface preparation, paint removal, and surface cleaning. The newly released CleanTech systems offer a non-abrasive cleaning process that is safer and more eco-friendly. Flexion technology provides a distinct advantage over other laser cleaning systems on the market. Flexion technology allows CleanTech to remove rust, paint, anodization, and other surface materials in areas that are typically difficult to reach. Most other systems are statically positioned which limits the laser cleaning ability to only the static path of the trajectory beam. As an analogy, imagine the sun and the direction of its rays hitting an object at 12 o’clock noon. The sun’s rays either hit the object directly over the top or depending on the object’s angle from the sun, it will hit the side of the object that is exposed to the sun’s rays, thereby leaving the other areas unaffected. The CleanTech Megacenter with Flexion technology offers a motion control stage that operates in both x and y axis, allowing the ability to move in various directions and clean nested parts under the path of the trajectory beam path (FIG. 1). This unique technology allows the laser cleaning process to efficiently affect 100% of all sides of the exposed parts. The Megacenter is available as a standalone or can easily be integrated into a production line. “Fonon’s Flexion technology opens the door for smaller companies to adopt the most advanced laser technology for modern manufacturing,” said Dmitriy Nikitin, CEO of Fonon. “Unlike other products, which are often simplistic and sometimes not even safe; we have invested the effort, the degree of difficulty, and the vision needed to build our Laser Cleaning Equipment with full compliance to OSHA, FDA, CDRH conforming to Class 1 Laser Safety “Push a Button” Industrial Operation. We are proud that our advanced line of CleanTech products is unmatched in the industry for meeting safety requirements and turnkey operation.” Dr. Nikitin continued,“We’ve already started booking orders for the first U.S.-based line of industrial laser cleaning equipment and the applications are endless; whether it’s aerospace depainting, marine rust removal, automotive pre-welding ablation, or hi-tech parts cleaning for bonding applications.” Made in America, Laser Photonics’ CleanTech product line can be used for various applications across a multitude of industries including: · paint and epoxy removal for items such as aviation parts · mold cleaning for the rubber and tire industries · corrosion removal for items such as surgical instruments Included in the line are the CleanTech Megacenter Stationary Unit; and the portable CleanTech Handheld which is useful in the field or on the factory floor. The CleanTech systems offer Class 1 enclosures for Class 4 lasers. Additionally, CleanTech has an integrated dust and residue collection system and can allow for a 3D scanner option to clean parts with complicated shapes. To learn more, visit http://www.laserphotonics.us/ Fonon Corporation is a laser-based R&D and manufacturing company, based in the United States, that provides comprehensive design and equipment to numerous industries worldwide including aerospace, automotive, defense, energy, food and beverage, industrial, medical, and semiconductor. Laser Photonics™, a Fonon brand, is the industry’s recognized #1 brand of industrial-grade fiber and CO2 laser equipment for marking, cutting, engraving, and surface cleaning or preparation. Fonon customers include Sony, NIKE, 3M, Delphi, NNSY-Norfolk Naval Shipyard, NASA, Cannon Air Force Base, Eaton Aerospace, GE, Caterpillar, Harley Davidson, PPG, Eli Lilly, Smith and Nephew, Millipore, DuPont, Bosch, Gables Engineering, Champion Aerospace, Smith Aerospace, Metaldyne, Dupont and Heraeus. For more information about Fonon, visit www.fonon.com.
Solar Atmospheres Inc., Souderton,Pa., announces that it has become the first company to receive MedAccred critical process re-accreditation. Furthermore, the company expanded its scope of accreditation to include Hardness Testing and Metallography & Microindentation Hardness. MedAccred is an industry-managed critical process supply chain oversight program developed by leading medical device companies to improve device quality and enhance patient safety. The effort to establish MedAccred began in 2010 when the Performance Review Institute (PRI) was asked to consider the development of a Nadcap style special process supplier accreditation program for the medical device industry. An industry roundtable was organized and convened in 2012 among interested medical device companies and PRI. Following this roundtable meeting, briefings were held with the FDA Center for Devices and Radiological Health's (CDRH) Office of Compliance and the FDA's Office of Global Operations within the Office of the Commissioner. The program purpose and scope was discussed, along with the results of proof of concept audits conducted to demonstrate the program's viability. The FDA provided positive feedback and strong encouragement to pursue the development of the program. By 2014, several critical process Task Groups were operating on a formal basis. Program documents were drafted, circulated, and approved by the executives of the participating companies, and audit criteria had been published in several critical process areas. Solar Atmospheres committed to hosting the first MedAccred audit. In early 2015, the first MedAccred critical process accreditation was issued to Solar Atmospheres or Heat Treating. Today's functioning critical process Task Groups include Cable & Wire Harnesses, Heat Treating, Plastics Injection Molding, Printed Circuit Board Assemblies, Sterilization, and Welding. The industry-managed task groups develop audit criteria, conduct audits, and award MedAccred Critical Process Accreditations to leading suppliers at all tiers in the Medical Device Supply Chain. Many companies are seeking MedAccred Accreditation to demonstrate their commitment to quality and patient safety. Future MedAccred Task Groups under consideration for development include Material Testing Laboratories, Assemblies, PCBs, Batteries, Chemical Processing, NDT, Cleaning, Coating, Optics, and Packaging. Active OEM and Contract Manufacturer participants include Johnson & Johnson, Philips, Stryker, GE Healthcare, Medtronic, NYPRO Jabil, Steris, etc. The list of participating suppliers is growing steadily.
News Article | November 11, 2016
Get ready for what 2017 holds. There will be a new president, a new congress and new medical device regulations and guidances. Come to the Press Club on December 1 and get a preview of what is coming. Attendees will hear directly from former FDA officials including Herbert Lerner, Heather Rosecrans, Minnie Baylor-Henry, Mary Pendergast, Casper Uldriks — and many other experts and veteran practitioners in medical device regulatory issues who have been or are now on the firing line of the current hot button issues in medical device law, regulation, and policy: cybersecurity, mobile apps and combination products. Not only will this be the first event of its kind after the election but it’s different. This FDAnews Summit is completely interactive — no slides— just questions, answers and discussion among the keynoter, moderators, panelists and the attendees. Meet the Keynote Speaker: Herbert Lerner, M.D., Senior Director of Regulatory and Clinical Sciences Hogan Lovells LLP Herb Lerner's practice focuses primary on bringing new medical devices to the U.S. market. Uniquely positioned to advise clients in addressing FDA regulatory issues, he brings to Hogan Lovells years of clinical practice and FDA regulatory experience. A clinician with almost 20 years as a general and colon & rectal surgeon, and former Deputy Division Director of the Division of Reproductive, Gastro-Renal, and Urological Devices, FDA/CDRH/ODE, Herb joined the Hogan Lovells Medical Device Group in 2016. About FDAnews FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
News Article | December 6, 2016
ISO 13485:2016 — Design Specifications and Preparing for Implementation: A 2 Part Series **An FDAnews On-Demand Webinar** Part 1 – Design Specifications: Dec. 20, 2016 ∙ 11:00 a.m. - 12:30 p.m. ET Part 2 – Preparing for Implementation: Dec. 20, 2016 ∙ 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/iso13485ondemand It’s been a big year for ISO 13485. FDAnews held two webinars earlier this year and wants to give manufacturers another opportunity to hear them in case they missed it the first time around. Listen to both webinars for the price of one. After dozens of years of the same old, same old ISO 13485 the first major revision to the standard has been introduced. What are the ins and outs of it? Will the requirements really be consistent with current cGMP and quality system requirements? What is the bottom line impact on CAPA, supply chain, adverse event reporting, environmental controls and complaint handling? FDAnews has compiled the most comprehensive presentations on the subject. Who better to explain the new requirements in Part 1 than Kim Trautman, Executive Vice President, NSF Health Sciences, Medical Device International Services and former Associate Director, International Affairs Office of CDRH. In Part 2 medical device regulations and standards expert, Dan O’Leary, president of Ombu Enterprises, will break down the standard line-by-line and explain everything manufacturers need to know to be fully prepared. Attendees will be able to understand: BONUS MATERIAL: Attendees will receive a comparative analysis of the changed requirements in ISO 13485:2016. It will identify ISO13485:2003 requirements and show the additions and deletions resulting from ISO 13485:2016. Register today to gain the most comprehensive understanding of the new ISO 13485 standard. Please note; these webinars were previously recorded and no questions will be taken during the presentation. Meet the Presenters: Kimberly Trautman Executive Vice President, NSF Health Sciences, Medical Device International Services Kim Trautman has more than 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program. Ms. Trautman previously worked for the FDA’s CDRH where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs and led continuing harmonization efforts with ISO 13485. Dan O’Leary, President, Ombu Enterprises, LLC Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years of experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs. Webinar Details: ISO 13485:2016 — Design Specifications and Preparing for Implementation: A 2 Part Series **An FDAnews On-Demand Webinar** Part 1 – Design Specifications: Dec. 16, 2016 ∙ 11:00 a.m. - 12:30 p.m. ET Part 2 – Preparing for Implementation: Dec. 16, 2016 ∙ 1:30 p.m. – 3:00 p.m. ET http://www.fdanews.com/iso13485ondemand About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.