- Generation of Overall Clinical Risk Benefit Reviews for compliance with the Medical Device Directive Annex I & Annex X.
- Identification of clinically relevant harms as required by ISO 14971 & ISO 62366.
- Training in and execution of failure modes effects and criticality analyses.
- Implementation of efficient product development procedures and integration of design history file documentation sets.
- Design verification and validation procedures and protocols.
- Process validation procedures and protocols. These establish the basis of scrap identification and tracking.
- Complaint system procedures with product development documentation and data sets integrated into the complaint reporting and analysis.
- Complaint and medical reviews.
- Management review procedures and processes.
- Supplier validation procedures and processes to meet requirements for which you, not the supplier, are responsible.