Template: ISO 13485: Mapping of Requirements to Documents
Template: Training Record
Template: Software Validation Form
Template: SOP Software Validation
Template: List of Qualified Suppliers
Template: Supplier Checklist
Template: List of Training Documentation
Template: SOP Human Resources Administration
Template: SOP Clinical Evaluation
Template: Management Review Report
Template: SOP Management Review
Template: SOP Internal Audit
Template: SOP Product Certification and Registration
Template: SOP Update of Regulations
Template: Incident Assessment Form
Template: Field Safety Notice
Template: SOP Feedback Management and Customer Complaints
Template: Document List QMS
Template: Post-Market Clinical Follow-Up Report (PMCFR)
Template: Post-Market Clinical Follow-Up Plan (PMCFP)
Template: Periodic Safety Update Report
Template: Post-Market Surveillance Plan
Template: SOP Post-Market Surveillance
Template: Quality Manual, Policy, Objectives
Template: SOP Document and Record Control
Template: SOP Corrective and Preventive Action (CAPA)