Date/TimeAugust 25, 2021
On July 23, 2021, NAMSA became the first-ever biocompatibility laboratory to be accredited by the FDA to the ASCA Pilot Program. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency.
The ASCA Pilot Program clears the first hurdle in the medical device premarket regulatory process for manufacturers submitting for clearance or approval to the FDA’s Centers for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
This webinar will discuss the ASCA Pilot Program, provide guidance tools and help manufacturers understand the process and responsibilities for all medical device testing stakeholders. This online event, 60 minutes in length, will also allow time for Q&A with our testing experts.
Join us as we answer the following questions:
- What is ASCA accreditation?
- What are the benefits of working with an ASCA-accredited biocompatibility laboratory?
- What are ASCA testing report responsibilities/requirements for manufacturers when submitting to the FDA for premarket approval?
- What are exclusion and inclusion criteria when performing ASCA testing?
- Where do I find additional FDA ASCA resources?
Melissa CadaretDirector of Global Compliance and Process Improvement
Melissa’s past experience includes serving as the Director of Analytical Services and Biocompatibility Laboratory Operations and Site Leadership for NAMSA’s Global Headquarters in Northwood (Toledo), Ohio. With more than 15 years of biocompatibility experience, Melissa is also currently a U.S. Expert on ISO TC 194: Biological Evaluation Medical Devices ANSI / AAMI/ ISO 10993. Melissa has a MS in Molecular Biology from Bowling Green State University and Bachelor’s degree in Biology from Southern Illinois University.
Sheri KrajewskiProduct Marketing Manager – Biological Safety
Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.