GMP AND CE CERTIFICATION CASE STUDY
CHALLENGE:
A major pharma company purchased a medical device business, seeking to achieve FDA clearance, CE certification and remain compliant under GMP regulations.
APPROACH:
An experienced AlvaMed team developed a project plan consistent with ISO 13485 and the European Union regulations. AlvaMed’s team:
- Performed a gap analysis
- Developed a project plan
- Provided training
- Managed a multi-site international implementation
- Influenced strategy for appropriate annex path certification
RESULTS:
Risk analyses and a 510(k) draft were completed on time; AlvaMed training and templates gave the client confidence to perform future risk analyses themselves.
