NAMSA is the World’s leading medtech cro offering global end-to-end development services
DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE
FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS COMPARED TO INDUSTRY AVERAGES
HELPING medical device SPONSORS IMPROVE HEALTHCARE SINCE 1967
Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA is a medical CRO offering only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.
As a medical contract research organization, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes. NAMSA’s offerings include medical device testing; regulatory, reimbursement and quality consulting; and clinical research services.
Learn from the world’s leading medical CRO with complimentary access to our latest white papers, webinars, and other resources to learn proven strategies and best practices for successful medical device development and commercialization outcomes.
Always on the pulse of industry news, we interpret the latest regulatory guidelines and other medical device updates so you don’t have to. Learn from the world’s most trusted medical device CRO to stay up-to-date on recent news and what it means for your medical device development plans and commercial operations.
Monkeypox: Not all EUAs Are Created Equal
The FDA declared a public health emergency for monkeypox on August 4, 2022 and authorized EUAs for diagnostic tests as of September 7, 2022. For this latest policy, the FDA is inviting experienced test developers with high manufacturing capacity to notify the FDA of their intent to submit an EUA request by October 13, 2022.
First Manual on Borderline and Classification under MDR Published by the European Commission
On the 7 September 2022, the European Commission announced publication of the latest manual on borderline and classification in the community regulatory framework for medical devices and In Vitro Diagnostic medical devices (Borderline Manual). This is the first version of the manual published under the requirements of the EU MDR.
NAMSA and InspireMD Announce Strategic Outsourcing Partnership to Accelerate New Product Development
NAMSA and InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention System (EPS) for treatment of carotid artery disease and prevention of stroke, announced today that they have entered into a strategic outsourcing partnership to accelerate medical device development and commercialization.
MDCG 2022-14: Transition to the MDR and IVDR - Notified Body Capacity and Availability of Medical Devices and IVDs
On 14 June 2022, the European Health Ministers met and echoed concerns surrounding the preparedness of medical device and IVD manufacturers for Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) conformity. If left unaddressed, the lack of preparedness may lead to the disruption of the supply of devices needed for health systems and patients, and could also jeopardize the access of innovative medical devices to the European market.
MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR
Assays used in clinical trials may range from CE-marked IVDs to trial- or medicinal product-specific assays that are not always meant to be developed as IVDs. In order to assure that conformity is maintained on both the drug and device sides, MDCG—with the Clinical Trials Expert Group (CTG)—have published a Q&A document to clarify requirements for these assays.
Let NAMSA’s medical device development experts guide you in the right direction.