- Authorised Representative according to ISO 13485: 2016
- CE Mark Strategy Consulting
- Gap analysis
- Design |Update Technical File
- Reviewing all existing documentation according to the applicable Essential Requirements
- Product classification
- Clinical Investigation Plan (CIP)
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Reports (CER)
- Biological Assessment Reports (BAR)
- Post Market Surveillance (PMS) Plan
- Post Market Surveillance (PMS) Reports
- Post Market Clinical Follow Up (PMCF) Protocol
- Periodic Safety Update Reports (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
- Labelling |Instructions For Use (IFU)
- Notified Body and EU Competent Authorities Contact
