NAMSA IS THE WORLD’S LEADING MEDTECH CRO OFFERING GLOBAL DEVELOPMENT SERVICES
DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE
FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS VS. 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.
FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents
At the end of July 2023, the United States Food and Drug Administration (FDA) issued a release indicating that they have recognized the following sterilization standard and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes.
The Swiss MedTech Landscape
Since May 2021, Switzerland's MRA with the EU is no longer applicable, posing potential challenges to the availability of medical products in the long term. To address this situation and avoid potential shortages of medical products, Switzerland has initiated the process of establishing mutual recognition agreements with other regions.
FDA Publishes Updated Guidance for Breakthrough Devices Program
On September 15, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Breakthrough Devices Program. This guidance updates the previous version of the guidance, of the same title, issued on December 18, 2018.
FDA Announces Three New Guidances Dedicated to 510(k) Submissions
On September 6, 2023, the U.S. Food and Drug Administration (FDA) released a statement about the issuance of the three new guidances as part of their effort to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices.
Mechanical Hemolysis Assay for Blood Contacting Devices
The Mechanical Hemolysis Assay is an in vitro test used to assess the potential for red blood cell damage by comparing the hemolytic effects of test articles with a reference device to determine their compatibility with blood contact.
Let NAMSA’s medical device development experts guide you in the right direction.