Silver Spring, MD, United States
Silver Spring, MD, United States

Time filter

Source Type

News Article | May 18, 2017
Site: www.prweb.com

A trail being blazed by provisions of the 21st Century Cures Act and proposed Medical Device User Fee Amendments (MDUFA) IV goals not to mention a business-friendly White House promise to decrease premarket-approval costs and speed new products to commercialization. All devicemakers have to do is figure it all out. FDAnews is here to help. Mark the calendar for Wednesday, June 7, and the Medical Device Premarket Regulatory Pathways webinar when two NSF Health Sciences senior consultants guide manufacturers down this new path to speedier premarket approvals. Attendees will discover: The presenters boast a wealth of premarket-approval experience. Caroline Rhim Ph.D. was Branch Chief-Anterior Spinal Devices, Office of Device Evaluation, CDRH, with deep experience involving premarket submission of novel orthopedic and cardiovascular devices. Meaghan Bailey RAC is an expert on preparing sponsors for Medical Devices Advisory Committee meetings and other premarket FDA interactions, and has been involved with premarket approval of in vitro diagnostics, and devices to treat and manage women’s health and diabetes. Greater profits, lower costs and speedier premarket approvals await the devicemaker who figures out these new advantages early on. 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.


WALTHAM, Mass., May 04, 2017 (GLOBE NEWSWIRE) -- EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced that it has submitted an Investigational Device Exemption (IDE) for the lead product in its cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform, EyeGate Ocular Bandage Gel (EyeGate OBG). The IDE, if accepted, will enable EyeGate to initiate a second pilot study of EyeGate OBG for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK). “The filing of this IDE represents an important step in the ongoing development of EyeGate OBG in corneal re-epithelialization. It comes as a direct result of our November 2016 pre-submission meeting with the FDA, at which the Agency confirmed that regulatory clearance via a De Novo 510(k) was the appropriate path forward for this novel medical device,” said Stephen From, President and Chief Executive Officer of EyeGate. “We are encouraged by our dialogue with the FDA to-date, which has clarified the clinical and regulatory path for our lead CMHA-S product candidate. We look forward to continued interaction during the IDE review process and are excited by the prospect of initiating this second pilot study, for which we expect top-line data in the second half of the year.” The IDE submission is subject to review by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), and must be approved prior to initiating this study. The review process is expected to take a minimum of 30 days, with the total duration of the review to depend on a variety of factors including the extent of potential comments, questions and additional information requested by CDRH / FDA and the timeliness of EyeGate’s responses to any such comments, questions or requests for information. The IDE for this study proposes a reading center masked trial enrolling up to 45 subjects undergoing a bilateral PRK procedure, and aims to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. Enrolled subjects will be randomized into three arms: The study’s primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3. About EyeGate: EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing products for treating diseases and disorders of the eye. EyeGate is developing products using CMHA-S, a modified form of the natural polymer hyaluronic acid (HA), which possesses unique physical and chemical properties such as hydration and healing properties. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries. EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. For more information, please visit www.EyeGatePharma.com. Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate OBG and EyeGate’s EGP-437 combination product, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.


WALTHAM, Mass., May 04, 2017 (GLOBE NEWSWIRE) -- EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced that it has submitted an Investigational Device Exemption (IDE) for the lead product in its cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform, EyeGate Ocular Bandage Gel (EyeGate OBG). The IDE, if accepted, will enable EyeGate to initiate a second pilot study of EyeGate OBG for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK). “The filing of this IDE represents an important step in the ongoing development of EyeGate OBG in corneal re-epithelialization. It comes as a direct result of our November 2016 pre-submission meeting with the FDA, at which the Agency confirmed that regulatory clearance via a De Novo 510(k) was the appropriate path forward for this novel medical device,” said Stephen From, President and Chief Executive Officer of EyeGate. “We are encouraged by our dialogue with the FDA to-date, which has clarified the clinical and regulatory path for our lead CMHA-S product candidate. We look forward to continued interaction during the IDE review process and are excited by the prospect of initiating this second pilot study, for which we expect top-line data in the second half of the year.” The IDE submission is subject to review by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), and must be approved prior to initiating this study. The review process is expected to take a minimum of 30 days, with the total duration of the review to depend on a variety of factors including the extent of potential comments, questions and additional information requested by CDRH / FDA and the timeliness of EyeGate’s responses to any such comments, questions or requests for information. The IDE for this study proposes a reading center masked trial enrolling up to 45 subjects undergoing a bilateral PRK procedure, and aims to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. Enrolled subjects will be randomized into three arms: The study’s primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3. About EyeGate: EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing products for treating diseases and disorders of the eye. EyeGate is developing products using CMHA-S, a modified form of the natural polymer hyaluronic acid (HA), which possesses unique physical and chemical properties such as hydration and healing properties. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries. EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. For more information, please visit www.EyeGatePharma.com. Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate OBG and EyeGate’s EGP-437 combination product, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.


WALTHAM, Mass., May 04, 2017 (GLOBE NEWSWIRE) -- EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced that it has submitted an Investigational Device Exemption (IDE) for the lead product in its cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform, EyeGate Ocular Bandage Gel (EyeGate OBG). The IDE, if accepted, will enable EyeGate to initiate a second pilot study of EyeGate OBG for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK). “The filing of this IDE represents an important step in the ongoing development of EyeGate OBG in corneal re-epithelialization. It comes as a direct result of our November 2016 pre-submission meeting with the FDA, at which the Agency confirmed that regulatory clearance via a De Novo 510(k) was the appropriate path forward for this novel medical device,” said Stephen From, President and Chief Executive Officer of EyeGate. “We are encouraged by our dialogue with the FDA to-date, which has clarified the clinical and regulatory path for our lead CMHA-S product candidate. We look forward to continued interaction during the IDE review process and are excited by the prospect of initiating this second pilot study, for which we expect top-line data in the second half of the year.” The IDE submission is subject to review by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), and must be approved prior to initiating this study. The review process is expected to take a minimum of 30 days, with the total duration of the review to depend on a variety of factors including the extent of potential comments, questions and additional information requested by CDRH / FDA and the timeliness of EyeGate’s responses to any such comments, questions or requests for information. The IDE for this study proposes a reading center masked trial enrolling up to 45 subjects undergoing a bilateral PRK procedure, and aims to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. Enrolled subjects will be randomized into three arms: The study’s primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3. About EyeGate: EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing products for treating diseases and disorders of the eye. EyeGate is developing products using CMHA-S, a modified form of the natural polymer hyaluronic acid (HA), which possesses unique physical and chemical properties such as hydration and healing properties. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries. EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. For more information, please visit www.EyeGatePharma.com. Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate OBG and EyeGate’s EGP-437 combination product, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.


WALTHAM, Mass., May 04, 2017 (GLOBE NEWSWIRE) -- EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a clinical-stage specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced that it has submitted an Investigational Device Exemption (IDE) for the lead product in its cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform, EyeGate Ocular Bandage Gel (EyeGate OBG). The IDE, if accepted, will enable EyeGate to initiate a second pilot study of EyeGate OBG for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK). “The filing of this IDE represents an important step in the ongoing development of EyeGate OBG in corneal re-epithelialization. It comes as a direct result of our November 2016 pre-submission meeting with the FDA, at which the Agency confirmed that regulatory clearance via a De Novo 510(k) was the appropriate path forward for this novel medical device,” said Stephen From, President and Chief Executive Officer of EyeGate. “We are encouraged by our dialogue with the FDA to-date, which has clarified the clinical and regulatory path for our lead CMHA-S product candidate. We look forward to continued interaction during the IDE review process and are excited by the prospect of initiating this second pilot study, for which we expect top-line data in the second half of the year.” The IDE submission is subject to review by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), and must be approved prior to initiating this study. The review process is expected to take a minimum of 30 days, with the total duration of the review to depend on a variety of factors including the extent of potential comments, questions and additional information requested by CDRH / FDA and the timeliness of EyeGate’s responses to any such comments, questions or requests for information. The IDE for this study proposes a reading center masked trial enrolling up to 45 subjects undergoing a bilateral PRK procedure, and aims to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. Enrolled subjects will be randomized into three arms: The study’s primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3. About EyeGate: EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing products for treating diseases and disorders of the eye. EyeGate is developing products using CMHA-S, a modified form of the natural polymer hyaluronic acid (HA), which possesses unique physical and chemical properties such as hydration and healing properties. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries. EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. For more information, please visit www.EyeGatePharma.com. Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate OBG and EyeGate’s EGP-437 combination product, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.


News Article | May 5, 2017
Site: www.prweb.com

Combination Products Regulation, Policy & Best Practices: It’s a Whole New Ballgame — Are You All In? **Presented by FDAnews** June 8, 2017, Washington, DC http://www.fdanews.com/comboregs Combination products are streaming to market just as Washington makes the game tougher to play. Manufacturers need to be on top of: It’s a lot to know and a lot to comply with. Before leaping forward with combination products, manufacturers need to get up to speed. Plan now to attend FDAnews’s first-ever all-day conference on combination products featuring 17 experts from every background — drugs, devices, biologics, generics, regulatory, legal, consulting and more. Attendees will be able to: Attendees will come away with a regulatory survival strategies including safety reporting and cGMP, advertising and marketing in the combination-products era, how to submit combination products directly to the CDRH and much more. Attend this all-day Washington event in person if possible — the networking opportunities alone justify the time and expense. If not the entire conference is being livestreamed at registration savings of $50. The combination-products train is leaving the station. Get on board with this full-day working session featuring 17 speakers including top regulatory lawyers, industry execs and knowledgeable consultants, and covering all the bases. Time is short though. Conference Details: Combination Products Regulation, Policy & Best Practices: It’s a Whole New Ballgame — Are You All In? **Presented by FDAnews** June 8, 2017, Washington, DC http://www.fdanews.com/comboregs 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 | April 19, 2017
Site: www.prnewswire.com

How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new report you find 247-page report you will receive 75 tables and 95 figures - all unavailable elsewhere. The 247-page report provides clear detailed insight into the global medical device contract manufacturing market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Assessment of the leading companies in the medical device contract manufacturing market: - Flextronics - Jabil Circuit - Benchmark Electronics - Greatbatch - The Tech Group (West Pharmaceutical Services) - Tecomet (Symmetry Medical) - Nortech Systems - TE Connectivity (Creganna Medical) - Forefront Medical Technology - Vention Medical • SWOT and Porter's Five Forces Analysis of the medical device contract manufacturing market Visiongain's study is intended for anyone requiring commercial analyses for the global medical device contract manufacturing market and leading companies. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongainglobal.com or call Tel: +44-(0)-20-7336-6100 ABT Medical AccuPlace Advanced Moulding Technologies Advanced Scientifics (Thermo Fisher Scientific) Advanced Semiconductors AdvantaPure Alcatel-Lucent Ansamed Applied Materials Asteel Flash ATEK Medical Group Avalon Medical Services Pte Ltd B Braun Bain Capital LLC Benchmark Electronics Beyonics Technology Blackberry Limited Boston Biomedical Associates (BBA) Boston Scientific C&J Industries Celestica Centro de Construccion de Cardioestimuladores del Uraguay (CCC) CIRTEC Medical Systems Cisco Systems Codman surgical instruments Cogmedix Covidien Creganna Medical CTS Corporation Da/Pro Rubber Dell Drager Medica DTR Medical DTS Mechelec Electrochem Medical Elementum Ericsson Europlaz Fast Forward Medical Filtertek Inc. Flextronics Forefront Medical Technology Foxconn (Hon Hai Precision Industries) Fresenius Greatbatch Medical GW Plastics Inc. Helix Medical Heraeus Medical Hewlett-Packard Honeywell Integer Jabil Johnson & Johnson Kimball Electronics Group Kitron Kohlberg Kravis Roberts & Co Lake Region Medical (Accellent) Lenovo Medefab Medtronic Meko Micro Power Electronics Microsoft Moog Motorola Mobility LLC NeuroNexus Technologies Inc Nortech Systems Nypro Inc Olsen Medical PCI Limited Phillips-Medisize Plasticos Castella Plexus Corporation Precision Wire Components LLC Research in Motion RiverTech Medical RIWISA AG Sanmina Saturn Electronics and Engineering Inc Sauflon Secant Medical Secure Technology Siemens Medical SIIX Corporation Smith & Nephew SMS Technologies St. Jude Medical Stryker Symmetry Medical (Tecomet) TE Connectivity The Electrolizing Corporation The Tech Group (West Pharmaceutical Services) Tricor Systems Vention Medical Venture Viasys Healthcare VicPlas International Ltd Wesley-Coe Winland Electronics Wytech Xerox Organisations Mentioned in the Report Agência Nacional de Vigilância Sanitária or National Health Surveillance Agency (ANVISA) Central Drug Standards Control Organisation (CDSCO) Centre for Devices and Radiological Health (CDRH) China Food and Drug Administration (CFDA) European Commission European Databank on Medical Devices (EUDAMED) The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) Food and Drugs Administration (FDA) The Ministry of Health, Labour and Welfare (MHLW) National Health and Planning Commission (NHPC) Servizio Sanitario Nazionale (SSN) [Italy] State Food and Drug Administration (SFDA) World Health Organization (WHO) World Trade Organization (WTO) To see a report overview please email Sara Peerun on sara.peerun@visiongainglobal.com


News Article | April 19, 2017
Site: www.prnewswire.co.uk

How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new report you find 247-page report you will receive 75 tables and 95 figures - all unavailable elsewhere. The 247-page report provides clear detailed insight into the global medical device contract manufacturing market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Assessment of the leading companies in the medical device contract manufacturing market: - Flextronics - Jabil Circuit - Benchmark Electronics - Greatbatch - The Tech Group (West Pharmaceutical Services) - Tecomet (Symmetry Medical) - Nortech Systems - TE Connectivity (Creganna Medical) - Forefront Medical Technology - Vention Medical • SWOT and Porter's Five Forces Analysis of the medical device contract manufacturing market Visiongain's study is intended for anyone requiring commercial analyses for the global medical device contract manufacturing market and leading companies. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongainglobal.com or call Tel: +44-(0)-20-7336-6100 ABT Medical AccuPlace Advanced Moulding Technologies Advanced Scientifics (Thermo Fisher Scientific) Advanced Semiconductors AdvantaPure Alcatel-Lucent Ansamed Applied Materials Asteel Flash ATEK Medical Group Avalon Medical Services Pte Ltd B Braun Bain Capital LLC Benchmark Electronics Beyonics Technology Blackberry Limited Boston Biomedical Associates (BBA) Boston Scientific C&J Industries Celestica Centro de Construccion de Cardioestimuladores del Uraguay (CCC) CIRTEC Medical Systems Cisco Systems Codman surgical instruments Cogmedix Covidien Creganna Medical CTS Corporation Da/Pro Rubber Dell Drager Medica DTR Medical DTS Mechelec Electrochem Medical Elementum Ericsson Europlaz Fast Forward Medical Filtertek Inc. Flextronics Forefront Medical Technology Foxconn (Hon Hai Precision Industries) Fresenius Greatbatch Medical GW Plastics Inc. Helix Medical Heraeus Medical Hewlett-Packard Honeywell Integer Jabil Johnson & Johnson Kimball Electronics Group Kitron Kohlberg Kravis Roberts & Co Lake Region Medical (Accellent) Lenovo Medefab Medtronic Meko Micro Power Electronics Microsoft Moog Motorola Mobility LLC NeuroNexus Technologies Inc Nortech Systems Nypro Inc Olsen Medical PCI Limited Phillips-Medisize Plasticos Castella Plexus Corporation Precision Wire Components LLC Research in Motion RiverTech Medical RIWISA AG Sanmina Saturn Electronics and Engineering Inc Sauflon Secant Medical Secure Technology Siemens Medical SIIX Corporation Smith & Nephew SMS Technologies St. Jude Medical Stryker Symmetry Medical (Tecomet) TE Connectivity The Electrolizing Corporation The Tech Group (West Pharmaceutical Services) Tricor Systems Vention Medical Venture Viasys Healthcare VicPlas International Ltd Wesley-Coe Winland Electronics Wytech Xerox Organisations Mentioned in the Report Agência Nacional de Vigilância Sanitária or National Health Surveillance Agency (ANVISA) Central Drug Standards Control Organisation (CDSCO) Centre for Devices and Radiological Health (CDRH) China Food and Drug Administration (CFDA) European Commission European Databank on Medical Devices (EUDAMED) The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) Food and Drugs Administration (FDA) The Ministry of Health, Labour and Welfare (MHLW) National Health and Planning Commission (NHPC) Servizio Sanitario Nazionale (SSN) [Italy] State Food and Drug Administration (SFDA) World Health Organization (WHO) World Trade Organization (WTO) To see a report overview please email Sara Peerun on sara.peerun@visiongainglobal.com

Loading CDRH collaborators
Loading CDRH collaborators