How we can support you
- EU MDR technical documentation preparation and review
- Clinical Evaluation Report (CER) support
- Post-market surveillance plans and reports
- Periodic Safety Update Reports (PSURs)
- Post-market clinical follow-up (PMCF) support
- Notified body findings and corrective action
- Training and team knowledge transfer
Bring the documentation together.
Technical documentation, clinical evidence, risk management and post-market activities need to tell a consistent story about your device. We help your team identify the work required, coordinate contributions and prepare or improve the relevant documentation.
Define a scope your team can execute.
Our support can focus on an individual report, a documentation gap, a notified body finding or a broader implementation project. We start with your device and existing evidence, then agree on priorities, deliverables and responsibilities.