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.
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.
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.
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.
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.