2. BEP, BER, CMR-ED, Gap Analysis of the existing documents, if any
3. Material Compliance
Key Responsibilities
- Define and execute biological evaluation strategies per ISO 10993 and EU MDR.
- Review material composition, supplier data, and existing biocompatibility evidence.
- Prepare or update Biological Evaluation Plans (BEPs) and Biological Evaluation Reports/Biological Risk Assessments (BERs/BRAs).
- Assess data gaps and recommend testing, literature review, or justification approaches.
- Collaborate with Toxicology and Risk Management teams for integrated assessments.
- Support responses to Notified Body queries related to biocompatibility.