Process and Test Method Validation Review and Improvement
Introduction
Cardiac Devices
Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide.
Apotech consultants
Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation.
Standards & Tools
- EU-MDR 2017-745
- FDA
- ISO 13485
- ISO 14971
- GDPR
- Word Excel, Powerpoint
Scope of work
Review of existing CAPA (for non-conformance and agreed corrective actions)
Comparison with regulatory requirements (EU MDR, FDA, ISO 13485)
Implementation and training on revised TMV
Review existing Process and TMV procedures/templates
Proposal of improvements to Process and TMV procedures/templates
Key numbers
Team
1 FTE
Location
Germany
Length
6 months (8 hours per week)
Type
Work Package
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