Join us for an informative webinar where we dive deep into the world of biological evaluation of medical devices using the international standard ISO 10993-1. This standard, titled "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," is a crucial guideline for ensuring the safety and efficacy of medical devices in the global market.
Key Highlights:
Why Attend?
Who Should Attend?
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO...