SCOPE OF WORK
To set up the whole QA/RA structure on behalf of the client
The client is a French start up developping a medical device Class IIb
DURATION & INVOICING
- Duration: 12 months
- Gap assessment invoiced on an hourly rate
- QA: QMS and process : Workpackage / Qualification + Validation invoiced on a daily rate
- RA: invoiced on a workpackage basis
OUTCOMES
- Gap assessment of the existing documentation and mapping of the medical device
- QA: QMS + Process + Risk assessment + Qualification/validation
- RA: technical dossier + CER
- Submission to the client