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 […]
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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 –
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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
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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.
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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
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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
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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
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The Usability Evaluation Plan outlines the activities and resources needed for conducting Usability Evaluation for the device. Mapping Standard Requirements to Document Sections IEC 62366-1:2015 Section Title Document Section 4.2 Usability Engineering File (all) 4.3 Tailoring the Usability Engineering effort
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Mapping Standard Requirements to Document Sections IEC 62366-1:2015 Section Title Document Section 5.4 Identification and Description of Hazard-Related Use Scenarios 1 5.5 Selection of Hazard-Related Use Scenarios for Summative Evaluation 1 Overview The purpose of the Hazard-Related Use Scenarios list
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Mapping Standard Requirements to Document Sections IEC 62366-1:2015 Section Title Document Section 4.2 Usability Engineering File (all) 4.3 Tailoring of the Usability Engineering effort (all) 1. User Group and Testing Environment Detail the user group here, such as physicians with
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