By Marcelo Trevino, senior VP, regulatory affairs and quality systems, Applied Medical
The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.
The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.
It is critical that companies in the medical device space have comprehensive, well-written, and descriptive procedures not only for documentation, but for assessing the impact of any and all changes, no matter how minor.
Mark Cusworth, VP of research and development at PRISYM ID, examines the EU Medical Device Regulation and its implications on labeling, and looks ahead to the future and the predicament companies will begin to face unless they start to make changes now.
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 Raghu Vadlamudi and Brian Woolery,Donatelle
The expectation for zero defects in medical devices is higher than ever. Manufacturers must find ways to achieve that expectation while reducing costs and risks. This article explains how automation can help manufacturers reach those goals.