Bioburden method validation template

Risk Management File (Set) Pre-clinical Testing (Set) Clinical Evaluation File (Set) Usability Engineering File (Set) Post Market Surveillance (PMS) (Set) Device Description & Specification Classification Report Similar Device Report Checklist for Artwork Checklist for Instructions for Use (IFU) Implant Card Implant Card Leaflet General Safety & Performance Requirements (GSPR) Risk Management Policy Risk Management Plan FMEA Table Risk Management Report Risk Management Team Biological Evaluation Plan Biological Evaluation Report Biological Safety Risk Assessment Identification of applicable biocompatible tests Post Market Clinical Follow-up (PMCF) Plan Post Market Clinical Follow-up (PMCF) Report Clinical Evaluation Plan Literature Search Protocol (LSP) Literature Appraisal Literature Search Report (LSR) Demonstration of Equivalence Vigilance Data Clinical Evaluation Report Usability Engineering Plan (Both UOUP and S+F) Usability Engineering Report (Both UOUP and S+F) SSCP (Summary of Safety and Clinical Performance) Declarations – Pack of all Post Market Surveillance (PMS) Plan Post Market Surveillance Report (PMSR) Periodic Safety Update Report (PSUR) Checklist – Company Profile Declaration of Conformity Summarized TCF Biological Evaluation Summary Plan Biological Evaluation Summary Report DoC Packaging Specifications Product List RM Specifications Person Responsible for Regulatory Compliance (PRRC) – appointment letter Accelerated stability study protocol Accelerated stability study report Real-time stability study protocol Real-time stability study report Design file ETO Validation (Over-Kill Approach) Gamma Sterilization Validation Steam sterilization Validation Packaging Validation Transportation Validation Injection Molding Validation Bio-Burden Method Validation Ultrasonic Cleaning Electropolishing Validation Anodizing Validation Approved Supplier List Supplier Agreements Distributor agreements Incoming Inspection / Quality Plan In-process Inspection / Quality Plan Final Inspection / Quality Plan Sampling Plan – variants based diff methods Quality Manual All quality procedures and formats as required by ISO 13485 All quality procedures and formats as required by ISO 13485 and 21 CFR Part 820 All quality procedures and formats as required by MDSAP Bioburden method validation Regulatory Strategy Other (Please specify in message)