• 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.
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