Top Featured Editorial
“Work Harder” — And Other Ways To Completely Miss The Mark On Quality
By Ben Locwin, Ph.D.

Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.

Unboxing The Results: The State Of Medical Devices Development Survey 2019
By Nico Kruger, Perforce Software

This annual survey of medical device professionals provides insight into how device development has changed in the past 12 months, current views on market challenges and trends, and the potential implications of these findings.

Understanding China’s Updated Overseas Inspections: A Q&A With Gert Bos And Michael Yan
By Zachary Brousseau, Regulatory Affairs Professionals Society

China’s National Medical Products Administration (NMPA) has stepped up overseas inspections in recent years, and manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors.

Top Industry Insights
Ensuring FDA Compliance: The Essential Guide To FDA 21 CFR Part 11
White Paper | PRISYM ID

FDA 21 CFR Part 11 allows medical device and life science organizations to use electronic records and signatures in place of paper. The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical product.

How To Recognize Effective CAPAs And A Culture Of Quality
Article | Flexan

When OEMs choose an outsourcing partner, they need to trust the effectiveness of the supplier’s CAPA program, and they need to trust that the supplier’s culture sustains quality each and every day, for every device.

Medical Device Design & Manufacturing Challenges: 2017 And Beyond
Article | By Dr. Frank Gindele, SCHOTT Electronic Packaging

Medical device manufacturers and designers must overcome various challenges to succeed in an expanding global marketplace, challenged along the way by aspects of design, research, validation, and bringing their devices to a competitive market in a cost-effective manner.

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