Manager of Biological Safety and Validation
Manager of Biological Safety and Validation, holds a Bachelor's degree from Ohio State University. Don has over 25 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.
- ISO 10993-1 2018 UPDATES: WHAT ARE THE RELEVENT CHANGES AND HOW IT IMPACTS THE BIOCOMPATIBILITY SAFETY EVALUATION PROCESS FOR MEDICAL DEVICE MANUFACTURERS - Hosted by NAMSA | Tue. February 5 - 8:30 AM - 9:10 AM
- EU MDR - ARE YOU PREPARED? IT'S NOT TOO LATE. THE SESSION WILL REVIEW THE GENERAL SAFETY & PERFORMANCE REQUIREMENTS OF THE EU MDR FOR THE BIOCOMPATIBILITY OF MEDICAL DEVICES - Hosted by NAMSA | Tue. February 5 - 9:50 AM - 10:30 AM
- Panel Discussion - Hosted by NAMSA | Tue. February 5 - 11:15 AM - 11:45 AM