Regulatory affairs

X

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

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