ISO 13485 Templates

Overview This SOP outlines the procedures for managing feedback and responding to customer complaints effectively. Process Owner \ Key Performance Indicators \ Regulatory References Regulation/Standard Relevant Sections Regulation 2017/745 (MDR) Articles 83-88 (Post-market surveillance, trend analysis, and vigilance) ISO 13485:2016 […]

1. General Information Audit Objective Internal audit Auditors List the names of internal auditors 2. Internal Participants Name Team Position/Role Audit Date Start Time End Time Scope Audit Criteria 3. Audit Activities Refer to Section 4 of the IAU –

This template serves as an example of the structure. It’s recommended to use Excel or Sheets instead of a Word document for better usability. Title / Doc-ID Doc Type Version Release Date Last Review Next Review Process Owner Comment SOP-Document

Summary This SOP ensures that only validated computer and software systems are used by the organization, preventing errors that could compromise the safety and performance of medical devices. It outlines the necessary validation requirements before a system can be utilized.

This document outlines the planning of all post-market clinical follow-up activities for the [name of the medical device]. Product Information Parameter Description Product or trade name: Model and type: Intended purpose: Context For additional guidance, refer to MDCG 2020-7: Post-market

Effective from DATE, the management of COMPANY NAME formally appoints PRRC name (company name, if external) as the Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of the EU Medical Device Regulation (EU) 2017/745 (MDR). COMPANY NAME

Regulatory Requirement Document Section Medical Device Regulation Article 7 All ISO 13485:2016 7.2 All Summary This SOP outlines the procedures for offering and selling the organization’s medical devices, including involvement in trials and research projects. It ensures that only approved