NAMSA is the World’s Only 100% Medical Device-Focused CRO offering global end-to-end development solutions…
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 offers only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.
Offering product development strategy; medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes.
Gain 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 what recent news means for your medical device development plans and commercial operations.
Industry Update: Accreditation Scheme for Conformity Assessment
As discussed in NAMSA’s December 19 blog post, “The Evolution of the Accreditation Scheme for Conformity Assessment,” ASCA is an assessment created by the U.S. Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA). The assessment was initiated as part of the enactment of the Medical Device User Fee 96 Amendments of 2017 (MDUFA IV).
FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin
Update: PMDA Review Timelines for Medical Device and IVD Products
The Pharmaceutical and Medical Devices Agency (PMDA) is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. One of the major functions of this agency is to review marketing applications of medical devices and in vitro diagnostic (IVD) products. In recent years, the PMDA has provided sponsors an annual report on review performance to assist in understanding the predictability and associated timelines for regulatory approval.
UKCA: A Wait and Watch Approach?
On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.
Partnering with Existing Owners and Management, ArchiMed Acquires Majority Interest in NAMSA, the World Leader in Medical Device Testing
Private equity healthcare specialist ArchiMed has acquired from the founding Gorski Family a majority stake in NAMSA, the only full continuum Contract Research Organization (CRO) in the world focused exclusively on medical devices. NAMSA’s President and CEO, John Gorski, the Gorski Family and senior managers will hold stake in the company amounting to a significant double-digit percentage. The price of the transaction is undisclosed.
Let NAMSA’s medical device development experts guide you in the right direction.