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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
Frame 1000005946

Scope of work

Done

Review of existing CAPA (for non-conformance and agreed corrective actions)

Done

Comparison with regulatory requirements (EU MDR, FDA, ISO 13485)

Done

Implementation and training on revised TMV

Done

Review existing Process and TMV procedures/templates

Done

Proposal of improvements to Process and TMV procedures/templates

Key numbers

Management

Team

1 FTE

Charity

Location

Germany

Combo Chart

Length

6 months (8 hours per week)

WeChat

Type

Work Package

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