Regulatory writing
In the following is a list of regulatory documents that AML Christensen can help your company create. Please be aware that this list is not exhaustive. As such, if you need help to develop a document that is not on the list, please do not hesitate to contact Anna to present your needs.
- Standard operating procedure (SOP)
- Literature review and Report
- State of the Art (SotA)
- Acceptance criteria
- Testing and Validation Protocols
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Performance Evaluation Plan (PEP)
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Performance Evaluation Report (PER)
- Clinical Investigation Plans and Reports for clinical trials
- Post Market Surveillance (PMS) Plan
- Periodic Safety Update Report (PSUR) / PMS Report
- Post Market Clinical Follow up (PMCF) Plan/Report
- Summary of Safety and Clinical Performance (SSCP)
- Risk Management file
- Biological Evaluation Plan (BEP)/Report (BER)
- Human factors engineering (HFE) and Usability Engineering Report (UER)
- Labelling and instructions for use (IFU)