Project goal
- Develop a Post-Market Clinical Follow-up (PMCF) Plan to address a major non-conformity as part of company’s CE renewal
Metrics for success
- Acceptance of plan by company’s Notified Body
Results
- Currently in progress
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Project goal
- Develop Clinical Evaluation Reports (CERs) to support the company’s application for CE marks for its ophthalmic lasers
Metrics for success
- Issuance of CE marks
Results
- CERs accepted by company’s Notified Body
Project goal
- Assist this OEM manufacturer with supporting documentation for its CE mark dossier for one of its product lines
Metrics of success
- Issuance of the CE mark
Results
- Currently in progress
