Our editor Laura Hughes highlights her five must-read articles for this week.
1. A manufacturer’s guide for EU MDR
Sandi Schaible, senior director of analytical chemistry and regulatory toxicology and Sherry Parker, senior director of regulatory toxicology, both from WuXi AppTec talk through what manufacturers need to know about the EU Medical Device Regulation (MDR).
2. The FDA responds to fears of nationwide shortages following the closure of two medtech sterilisation plants
There are fears the closure of two medtech sterilisation plants could result in years of nationwide shortages for a number of surgical kits and implantable medical devices.
3. Evonik launches world’s first bioresorbable copolymers for medical device applications
Specialty chemicals company Evonik claims to have launched the world’s first bioresorbable portfolio of polylactide-polyethylene glycol (PLA-PEG) copolymers for use in implantable medical device applications.
4. Through the fog: ISO 10993-1:2018 explained
MPN editor Laura Hughes sat down with Beau Rollins, global director of quality services for ConvaTec, to better understand ISO 10993-1:2018 and learn about how medical device manufacturers can ensure compliance with regulatory requirements.
5. Phillips-Medisize to launch its first combination and electronic-enabled drug delivery device
Phillips-Medisize announced plans to manufacture a wearable drug and device combination product for a leading biotechnology player.