NAMSA

Chasse-sur-Rhône, France
Chasse-sur-Rhône, France
SEARCH FILTERS
Time filter
Source Type

TOLEDO, Ohio & FT. LAUDERDALE, Fla.--(BUSINESS WIRE)--NAMSA®, the world’s only Medical Research Organization (MRO®) that accelerates medical device development through integrated laboratory, clinical and consulting services, is pleased to announce its partnership with NAGLREITER™ Medical Device Development Organization (MDDO), a high-growth medical device design, development and manufacturing firm. For nearly 50 years, NAMSA has focused on offering the most critical services required to accelerate time-to-market and reduce costs for medical device research clients across the world. Consistently recognized as a pioneer in medical device development – most recently with the honor of the “CRO Leadership Award,” presented by Life Science Leader magazine – NAMSA has a proven and established track record of delivering expedited results through the utilization of its translational research methods. NAGLREITER, similarly placing a significant concentration on providing efficacious customer outcomes, applies an integrated approach within its design, development and manufacturing service offerings. Providing end-to-end solutions for over 20 years, NAGLREITER focuses on technical and design alternatives that reduce costs and fast-track timelines that move clients into device production as quickly as possible. This partnership, drawing upon a combined 70 years’ experience in assisting thousands of customers to successfully commercialize products throughout the world, will now provide early-stage medical device firms a single source, power house solution through its combined full service offering. John Amat, NAMSA’s Chief Commercial Officer, said in support of the collaboration, “We are extremely excited about this unique partnership that will result in more predictable development timelines, increased cost savings and unparalleled time-to-market for device firms. NAGLREITER’s ‘Product Lifecycle Management’ methodology of innovation perfectly complements NAMSA’s ‘MRO Approach.’ Together, we will be able to more effectively drive start-up device programs and appropriately address the challenges and risks that these organizations face due to fragmented resources and increasingly complicated regulatory landscapes.” President of NAGLREITER, Brett Naglreiter, also commenting on the collaboration, stated, “NAGLREITER’s year-over-year success has opened up this exclusive opportunity to join forces with the leader in global medical device research. We fully expect our partnership to provide customers with further efficiencies that result from having access to a comprehensive portfolio of development resources and commercialization services that are managed through a single source.” NAMSA and NAGLREITER look forward to providing early-stage medical device organizations with a unique, world-class solution that will allow them to bring life-changing therapies to the marketplace in the most efficient manner possible. Medical device firms wishing to learn more about this partnership program may contact us at info@namsa.com or (866) 666-9455. NAMSA is the world’s only Medical Research Organization (MRO) that accelerates medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world. NAGLREITER Medical Device Development Organization (MDDO) is a trusted partner for concept incubation, design, development and manufacturing engineering services within the Medtech industry. NAGLREITER prides itself on providing world-class services and employing a uniquely flexible business model to do so. NAGLREITER’s ‘The Right Path. With You’ business philosophy exemplifies the company’s commitment to partnering with clients in any way they require to yield the best possible outcomes. Based in the Ft. Lauderdale area in Miramar, Florida, NAGLREITER partners with medical device companies within the U.S. and abroad.


News Article | July 17, 2017
Site: www.businesswire.com

東京--(BUSINESS WIRE)--(ビジネスワイヤ) -- 統合的なラボ・臨床・助言サービスを通じて医療機器開発を加速する世界で唯一の医学研究組織(MRO)であるNAMSAは、新たな日本語ウェブサイトを立ち上げることを発表します。 この期待の高いウェブサイトの開設は、NAMSAの統合医療機器開発サービスの日本全域における需要増を直接反映したものです。2016年に医療機器市場で532億ドルを生み出した日本は、世界第3位の医療製品市場であり、2020年まで着実に成長すると期待されています(GlobalData)。 NAMSAジャパンのゼネラルマネジャーのテリー・ツジは、次のように述べています。「お客さまにより良いサービスを提供すべく、初の日本語ウェブサイトを開設できることを非常にうれしく思います。この利用しやすく情報満載のウェブサイトは、日本での大幅な成長を支え、日本のメーカーは今後、効率的で費用対効果の高い医療機器開発に向けた実証済みの単一ソースソリューションをより簡単に特定できるようになります。」 京都と東京に2つの事務所を構えるNAMSAは、医療機器の開発と市場投入を加速さ


TOKYO--(BUSINESS WIRE)--NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical and consulting services is excited to announce the launch of its newly developed Japanese website. The introduction of this highly-anticipated website is a direct result of the increased demand for NAMSA’s integrated medical device development services throughout Japan. Generating $53.2B in the medical device equipment market in 2016, Japan ranks as the world’s third largest medical product marketplace and is expected to grow steadily through 2020 (GlobalData). “We’re extremely pleased to launch our first ever Japanese website to better serve our clients. This user-friendly and information-filled resource will not only help support our significant growth in Japan, but will also allow Japanese manufacturers to more easily identify a proven, single source solution for efficient and cost-effective medical device development,” commented Terry Tsuji, General Manager, NAMSA Japan. NAMSA, with two Japanese office locations in Kyoto and Tokyo, provides clients with highly sought after testing, clinical and regulatory services required to accelerate medical device development and market introduction. Japanese medical device manufacturers wishing to learn more about NAMSA’s services are encouraged to visit http://namsa.co.jp/ or to email NAMSA’s team of experts at japansales@namsa.com. NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world. NAMSA operates 13 offices throughout North America, Europe, the Middle East and Asia, and employs nearly 1,000 highly-experienced laboratory, clinical and consulting Associates.


News Article | June 6, 2017
Site: www.businesswire.com

TOLEDO, Ohio--(BUSINESS WIRE)--NAMSA, the world’s only Medical Research Organization (MRO®) that accelerates medical device development through integrated laboratory, clinical and consulting services, will celebrate its 50th anniversary on June 29, 2017. NAMSA, founded in 1967, was the first independent company in the world to focus solely on testing medical devices and materials. Established nearly ten years before the Food & Drug Administration (FDA) began to regulate medical devices, NAMSA is proud to have acted as a key contributor to the development of test methods that still govern the international medical device industry today. “Over the course of 50 years, NAMSA has remained a market leader throughout the many changes presented by the global economic climate and medical device marketplace,” commented John Gorski, President & CEO, NAMSA. “Our success is attributed in part to our willingness and ability to innovate effective ways to accelerate clients’ time-to-market while assuring product safety and efficacy for patients,” he continued. NAMSA’s mission of “making a scientific contribution to every medical device in the world,” has been a guiding force in the company’s growth and expansive global reach. Employing 1,000 Associates, NAMSA currently offers medical device development services in 13 locations throughout Asia, Europe, Latin America, the Middle East and North America. The organization serves as the world’s only MRO that assists clients in reducing development costs and accelerating market introduction through the utilization of its testing, clinical and consulting services. “It is with the passion of our talented and highly experienced Associates that we celebrate this milestone anniversary,” said Mr. Gorski. “I’m proud to say that our teams consistently exceed client expectations by providing the most efficient, best-aligned and proactive solutions to each and every project. We understand the importance of our work and the potential it has to positively impact patient health worldwide. Our Associates’ dedication to customer success will undoubtedly help guide the way for our next 50 years of business,” Gorski concluded. NAMSA will hold a special celebration at its headquarters in Toledo, Ohio on June 29, 2017. NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world.


News Article | May 9, 2017
Site: www.businesswire.com

TOLEDO, Ohio--(BUSINESS WIRE)--NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical and consulting services, announced today that it has been recognized for excellence in clinical research and honored as a 2017 “CRO Leadership Award” winner. The CRO Leadership Awards are issued by Life Science Leader magazine and are based on data gathered by Industry Standard Research, a full-service biotechnology market research firm. Recipients of this prestigious award are selected based on data-driven feedback from those who have recently utilized clinical services in 27 key CRO performance categories, including Compatibility, Capabilities, Expertise, Quality and Reliability. “The CROs receiving an award this year are truly at the top of their class, and are deserving of the recognition they receive. Being ranked a top performer demonstrates a level of expertise and commitment to clinical trials and an ability to serve the needs of biopharmaceutical companies and their patients. Medical device sponsors can now make better-informed decisions when selecting a trusted, performance-driven CRO to assist in their clinical trials,” stated Ed Miseta, Executive Editor, Life Science Leader. “NAMSA is incredibly proud to be recognized by fellow industry executives as a leading CRO. This significant recognition is a direct result of our laser-like focus on accelerating medical device development and commercialization efforts for thousands of clients worldwide,” said John Gorski, NAMSA President & CEO. For nearly 50 years, NAMSA has focused on helping thousands of global customers succeed by offering the most critical services required to accelerate time-to-market and reduce costs for medical device research. Consistently recognized as a leader in medical device development – with a proven and established track record – NAMSA continuously places a dedicated focus on assisting clients in bringing life-changing therapies to the marketplace in the most efficient manner possible. Gorski continued, “Our experienced teams consistently deliver superior results for clients throughout the full spectrum of product development, including clinical research. By combining the knowledge of our dedicated Associates with our translational research approach, customers not only achieve clinical endpoints more quickly, but are also able to make more effective key commercialization decisions that lead to success.” NAMSA operates 13 offices throughout North America, Europe, the Middle East and Asia, and employs nearly 1,000 highly-experienced laboratory, clinical and consulting Associates. NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world.


News Article | February 15, 2017
Site: www.marketwired.com

The session will focus on various aspects of designing and conducting clinical trials for submission to the FDA, as well as, communicating with FDA during the pre-submission and submission process TORONTO, ON--(Marketwired - February 13, 2017) - On Tuesday, March 7, 2017, Xtalks will host a complimentary webinar featuring Richard Kotz, Senior Medical Research Scientist, Biostatistics from NAMSA as the keynote speaker. The advice provided during the session will be based on Richard Kotz's 25 years of experience gained as a statistical reviewer and biostatistics team leader at FDA's Center for Devices and Radiological Health. He, along with his team of biostatisticians, has reviewed 100's of medical devices for a wide variety of medical conditions. He has also participated in numerous FDA/sponsor meetings. Utilizing this experience and expertise, Mr. Kotz will share insights into key topics related to successful study design, with an emphasis on those trial elements which were most likely to lead to poorly designed and executed clinical trials. The discussion will provide best practices and tips on getting the most out of communications with the FDA and include a Q&A period with the audience. For more information or to register for this free webinar visit: Designing an Effective Clinical Trial Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies to private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit http://xtalks.com For information about hosting a webinar visit http://xtalks.com/sponsorship.ashx


McKim Jr. J.M.,CeeTox Inc. | Keller III D.J.,CeeTox Inc. | Gorski J.R.,Namsa
Cutaneous and Ocular Toxicology | Year: 2012

Chemical sensitization is a serious condition caused by small reactive molecules and is characterized by a delayed type hypersensitivity known as allergic contact dermatitis (ACD). Contact with these molecules via dermal exposure represent a significant concern for chemical manufacturers. Recent legislation in the EU has created the need to develop non-animal alternative methods for many routine safety studies including sensitization. Although most of the alternative research has focused on pure chemicals that possess reasonable solubility properties, it is important for any successful in vitro method to have the ability to test compounds with low aqueous solubility. This is especially true for the medical device industry where device extracts must be prepared in both polar and non-polar vehicles in order to evaluate chemical sensitization. The aim of this research was to demonstrate the functionality and applicability of the human reconstituted skin models (MatTek Epiderm ® and SkinEthic RHE) as a test system for the evaluation of chemical sensitization and its potential use for medical device testing. In addition, the development of the human 3D skin model should allow the in vitro sensitization assay to be used for finished product testing in the personal care, cosmetics, and pharmaceutical industries. This approach combines solubility, chemical reactivity, cytotoxicity, and activation of the Nrf2/ARE expression pathway to identify and categorize chemical sensitizers. Known chemical sensitizers representing extreme/strong-, moderate-, weak-, and non-sensitizing potency categories were first evaluated in the skin models at six exposure concentrations ranging from 0.1 to 2500 M for 24 h. The expression of eight Nrf2/ARE, one AhR/XRE and two Nrf1/MRE controlled gene were measured by qRT-PCR. The fold-induction at each exposure concentration was combined with reactivity and cytotoxicity data to determine the sensitization potential. The results demonstrated that both the MatTek and SkinEthic models performed in a manner consistent with data previously reported with the human keratinocyte (HaCaT) cell line. The system was tested further by evaluating chemicals known to be associated with the manufacture of medical devices. In all cases, the human skin models performed as well or better than the HaCaT cell model previously evaluated. In addition, this study identifies a clear unifying trigger that controls both the Nrf2/ARE pathway and essential biochemical events required for the development of ACD. Finally, this study has demonstrated that by utilizing human reconstructed skin models, it is possible to evaluate non-polar extracts from medical devices and low solubility finished products. © 2012 Informa Healthcare USA, Inc.


News Article | November 3, 2016
Site: www.businesswire.com

TOLEDO, Ohio & SHANGHAI--(BUSINESS WIRE)--#clinicalresearch--NAMSA, the world’s only Medical Research Organization (MRO), is pleased to announce the opening of its 80,000 sq. ft. preclinical medical device research laboratory in Shanghai, China.


TOLEDO, Ohio--(BUSINESS WIRE)--NAMSA, the world’s only Medical Research Organization (MRO), is pleased to announce the expansion of its global MRO Summit series. NAMSA’s MRO Summits will now offer further, complimentary educational events for medical device professionals wishing to gain direct access to consulting, testing and clinical resources worldwide. During its 50 year history, NAMSA has supported thousands of clients throughout all stages of the medical device development lifecycle, and has established a successful track record of accelerating time-to-market and reducing costs associated with clinical research and market approval. “The expansion of our MRO Summit series will allow us to share our global knowledge and scientific expertise on a wider scale by offering unique, real-world learning opportunities presented by NAMSA’s industry experts,” commented Christopher Rupp, NAMSA’s Director of Global Marketing. “We are extremely excited to present our shared experiences surrounding efficient medical device development, and to offer unique networking opportunities that allow medical device professional’s direct access to NAMSA’s knowledgeable, experienced thought leaders.” With over 15 events throughout 2017, attendees can expect to gain knowledge regarding best practices and suggested strategies for medical device development success across the following areas: To learn more about the MRO Summit series, with programs offered throughout the Americas, Asia and Europe – or to register – please visit the NAMSA website by clicking here. We also invite you to learn more about how NAMSA is assisting medical device clients to enhance patient safety and improve healthcare worldwide by contacting us at: clientcare@namsa.com. NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.


MINNEAPOLIS & TOLDEO, Ohio--(BUSINESS WIRE)--#clinicalresearch--NAMSA Expands Medical Device Clinical and Consulting Services Presence in Minneapolis to Accommodate Growth

Loading NAMSA collaborators
Loading NAMSA collaborators