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.
The Situation
- 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
The Solution
- USDM met with lead regulatory and quality executives to review the process and sequence of activities
- USDM inventoried all policies and procedures that were affected by EU MDR and reviewed all necessary documents
- USDM also reviewed other policies and procedures to ensure they were not relevant to EU MDR initiatives
- USDM then assigned select regulatory consultants, based on skill set and experience, to review and redline policies and procedures in their respective area of expertise
- All proposed revisions were reviewed with the relevant regulatory and quality managers
- USDM also provided support for the SOPs submission processes for device recertification
The Results
- < 8 month timeline to establish Quality System to meet EU MDR requirements
- $3B in revenue risk reduction across EU
- Ready to submit data to European Database on Medical Devices (EUDAMED)