ISO 13485 Bundle | All templates for EN ISO 13485:2016+A11:2021

This bundle pack of documents provides all required document templates to demonstrate conformity to ISO 13485:2016+A11:2021 This template bundle is the best option for companies starting a Quality Management System (QMS) from scratch and require all documents and forms. Within this bundle are templates for:

• Quality Manual 
• Quality Policy
• Quality Objectives
• Quality Procedures (QP)
• Forms for Quality Records (QR)

A full list of templates with the bundle are as follows:

• Software Validation and Revalidation Procedure
• Master software list
• Software acceptance testing template
• Quality Manual
• Medical Device File Template – IVDR (EU)
• Medical Device File Template – MDR (EU)
• Declaration of Conformity Template
• GSPR Template IVDR
• GSPR Template MDR
• Risk Management Plan
• Medical Device Risk Identification Analysis and Control
• Medical Device Risk Evaluation and Risk Benefit
• Medical Device PMS (post market surveillance) Plan
• Control of Documents procedure
• Change control log
• Master Document list
• Control of Records procedure
• Quality Policy Template
• Quality Objectives Template
• QMS Planning Procedure
• Management Review Procedure
• Management Review Meetings Agenda Template
• Management Review Meetings Minutes Template
• Training and Qualification Procedure
• Employee Induction Template
• Training Matrix Template
• Training Record Template
• Job Description Template
• Infrastructure, work environment and Contamination Control Procedure
• Product Realization Planning Procedure
• Risk Management Procedure
• Strategic Risk Register Template
• Customer Related Processes Procedure
• Design and Development Procedure
• Supplier Evaluation and Monitoring Procedure
• Supplier Evaluation Form Template
• Approved Supplier List Template
• Purchasing Procedure
• Receiving Goods in inspection template
• Device History Record Template
• Requirements for the cleanliness of Products Procedure
• Requirements for Installation Activities Template
• Requirements for Servicing Activities Template
• Process Validation Procedure
• Validation of sterilisation and Sterile Barrier Systems Procedure
• Product Identification and Traceability Procedure
• Control of Monitoring and Measuring Equipment Procedure
• Feedback Procedure
• Complaints Procedure
• Complaints Database template
• Complaint Investigation Form
• Reporting to Regulatory Authorities and Vigilance Procedure
• Internal Audit Procedure
• Internal Audit Schedule Template
• Internal Audit Plan Template
• Audit Report Template
• Non-Conformance Procedure
• Non-Conformance Report Log Template
• Non-Conformance Report Template
• Rework Procedure
• Measurement and Analysis Procedure
• Corrective and Preventative Action Procedure
• CAPA Log
• CAPA Report Form

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.