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.
UK MHRA Advisory Group Publishes Proposals
On 7 March, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published the minutes of their Advisory Group, recommending ten (10) specific proposals to International Recognition, Routes for Innovation and System Capacity.
European Parliament to Amend MDR/IVDR Transitional Provisions
On 16 February 2023, the European Parliament voted to adopt an amendment that affects Article 120 and Article 110 of Regulations (EU) 2017/745 and (EU) 2017/746, respectively. The amendment only extends the transitional period for legacy medical devices, but also removes the sell-off period for both medical and in vitro diagnostic (IVD) devices.
U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry
During the COVID-19 Pandemic, the FDA CDRH put the hardest, longest and most intensive work into reviewing EUA applications for COVID-19 diagnostic tests. The result was a shift in how the FDA, MedTech manufacturers and CROs conduct work, which is still in place today.
Health Canada and FDA eSTAR Pilot
On January 10, 2023, the U.S. Food and Drug Administration (FDA) and Health Canada announced a new joint pilot program. This program will conduct tests on the use of FDA’s eSTAR to make a single medical device submission to both FDA and Health Canada.
The Value of Economic Data in Payor Engagement
Economic data can be any data that tells a utility or benefit story. It can include health economics and outcomes research (HEOR) which measures and generates evidence of a product’s value and impact to support reimbursement and market access. But, for purposes of this blog post, we will use the term ‘economic data’ more broadly than the term HEOR.
Let NAMSA’s medical device development experts guide you in the right direction.