As an analytical testing partner to the medical device industry, it is the laboratory’s responsibility to have a deep understanding of these standards and regulations. Laboratories can help clients not only make the most appropriate choice in the analytical technique and test to solve their problems but also make sure the testing performed will meet the regulatory scrutiny needed to bring safe and effective products to market.
This white paper presents a brief history of medical device regulations, and discusses how the requirements apply to analytical testing of medical devices, including GLPs, GMPs and ISO 17025. A recommended decision tree is presented, to help determine what set of regulatory requirements are needed for medical device testing.
Download our white paper today, and contact us with your questions about your medical device regulations challenges.