Learn how USDM Life Sciences helped a large medical device manufacturer upgrade their Quality System by revising 400 SOPs, generating CND codes for EUDAMED submissions, and easing concerns for how to plan for recall items.
Meeting MDR Requirements
The company needed a submission process to get all existing devices recertified under the MDR requirements which include re-certification of the notified bodies, new submission requirements including new clinical, evidence, reasoning (CER) forms, new post-marketing safety analysis, and reporting requirements, and changes to the device technical files and dossiers.
- Large Medical Device Manufacturer
- Products in multiple countries
- The company's QMS system and 400 SOPs required review and revisions
- CND codes for EUDAMED submission were needed
- The company was concerned on how to plan for recalls by item