ISO 13485:2016 Section Document Section 8.5.2 (All) 8.5.3 (All) Overview This document provides a comprehensive record of all Corrective and Preventive Actions (CAPAs). CAPA Details Adverse Implications: Ensuring that corrective or preventive actions do not negatively impact compliance with regulatory […]
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List all software used either in your Quality Management System (QMS) or during product development. This typically includes tools like Slack, GitHub, Integrated Development Environments (IDEs) such as IntelliJ, and programming libraries utilized exclusively during development. Note: Libraries included in
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Regulatory Requirement Document Section ISO 13485:2016 Section 8.2.4 Entire Document Overview This SOP outlines the procedure for conducting internal audits to assess compliance with regulatory standards. It is applicable for both internal and supplier audits. Process Owner \ Key Performance
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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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