News

QA Consulting, Inc. Receives ISO 13485:2016 Certification for Medical Device Consulting Services

Austin, TX, May 19, 2017 - QA Consulting announced today that it has received ISO 13485:2016 certification  to provide medical device consulting services for quality management system (QMS) implementation and maintenance, regulatory affairs, and microbiological services following a successful audit conducted by the BSI Group. “We are proud to be one of the first medical…
Read more

Dissecting the FDA’s Expectations for Biocompatibility of Medical Devices: Five Key Considerations

The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process replacing the historical "Blue Book Memorandum #G95-1" (1995). The new guidance, released in June, is a substantial upgrade from its predecessor and serves the purpose of guiding…
Read more

Five Strategies for Effective Supplier Management

Medical device manufacturers commonly use outsourced suppliers for device components, assembly, packaging, labeling, and sterilization. An outsourced supplier may even produce the entire finished device under the manufacturer’s brand name. In all of these instances, it is ultimately the manufacturer’s (specification developer’s) responsibility, not the outsourced supplier, to ensure that the devices meet all specifications. To meet this responsibility,…
Read more