The purpose of this training is to clarify the requirements of Meddev 2.7.1 rev.04 and A Guide For Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC and share information about how to meet these requirements. Training will be done through sample documents and records.
Content of Clinical Evaluation Meddev 2.7.1 rev.04
What is a clinical evaluation?
In what situations clinical evaluation should be conducted?
What is the role of clinical evaluation in first and routine certification?
How to update the clinical evaluation?
How to conduct a clinical evaluation?
Who can conduct a clinical evaluation?
How to compose a clinical evaluation report?
What is equivalency? How to show equivalency?
Who Should Join to Meddev 2.7.1 rev.04 Training?
Employees of quality, top management, production, design and development departments
ISO 13485 Standard Internal Audit Candidates
Each candidate will receive “Clinical Evaluation Informational and Certification Training Certificate”.