Medical Device Development & Regulatory Webinars

NAMSA is committed to not only offering the most in-depth clinical research organization (CRO) consulting, the best and most cutting edge laboratory testing, and the most efficient and productive clinical trial services, but we are also committed to providing the latest information and thought leadership across the industry and across the globe. NAMSA webinars provide insights and understanding regarding today’s testing standards and tomorrow’s regulatory changes.

Archived Webinars

Title
Release Date
CFDA Acceptance of Overseas Clinical Trial Data: Understanding the Impact to Medical Device Manufacturers
April 20, 2018
ISO 10993-1: Understanding the Use & Value of Biocompatibility Safety Evaluation and Risk Assessment Standards for Medical Devices
April 11, 2018
Leveraging Post-Market Surveillance & Clinical Follow-Up Data to Support EU MDR Compliance
March 27, 2018
How to Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
February 21, 2018
U.S. FDA Advisory Panel Meetings: Strategies to Maximize Success
December 07, 2017
ISO 10993 Update: Understanding the Use and Value of Biocompatibility Standards for Medical Devices
November 29, 2017
ISO 13485:2016: How to Incorporate Risk-Based Quality Systems that Lead to Efficient Decision Making
October 23, 2017
ISO 13485:2016: How to Incorporate Risk-Based Quality Systems that Lead to Efficient Decision Making
October 19, 2017
Design and impact of Preclinical Studies Throughout the Product Development and Commercialization Process
September 12, 2017
Design and impact of Preclinical Studies Throughout the Product Development and Commercialization Process
September 07, 2017
ISO 13485:2016: Ensuring a Smooth Transition through Effective Preparation
August 31, 2017
Understanding Medical Device Regulatory Pathways in China and Japan
July 20, 2017
Understanding the FDA/CMS Parallel Review Process and How to Reduce the Gap Between FDA Approval and Payer Coverage
July 18, 2017
Clinical Studies in China- Understanding the Regulatory Framework and Trial Process
June 07, 2017
EU IVD Regulation: Top Five Changes for Medical Device Manufacturers to Consider
May 25, 2017
The Purpose and Value of Chemical Characterization and Biological Risk Assessment in Medical Device Development
May 23, 2017
SAE Reporting Requirements in Germany and Austria
June 20, 2016
Updates to USP 661: USP 661.1 Plastic Materials of Construction
April 19, 2016
Applying Human Factors and Usability Engineering to Medical Devices
March 29, 2016