Document Templates

Regulatory Requirement Document Section MDR Annex XIV All MEDDEV 2.7/1, rev. 4 All MDCG 2020-6 All Overview This SOP outlines the process for developing medical devices in compliance with the regulatory requirements of MDR Annex XIV regarding clinical performance. It […]

NOTE: This template is intended to illustrate the structure. It is recommended to use Excel or Sheets rather than a word document for better functionality. Additionally, organize your categories as columns and suppliers as rows – this template is presented

Regulatory Requirement Document Section ISO 13485:2016 Section 5.6 Entire Document Overview This SOP outlines the process for conducting surveillance of the quality management system (QMS) to confirm its ongoing appropriateness, effectiveness, and efficiency. Regular Management Reviews are conducted to document

1. General Information Field Details Audit Program \ Year Audit Number Field Details Audit Team \<list auditors’ names> Audit Type \<e.g., internal (first-party) audit> Audit Scope In accordance with audit plan, para. 4 Audit Date Audit Time \<e.g., 09:00 –

This report outlines the post-market surveillance activities related to a specific product, as detailed in the Post-Market Surveillance Plan. 1. Executive Summary Summarize the key findings of the current PSUR and provide essential background information to make the PSUR self-contained.

ISO 13485:2016 Section Document Section 4.1.1 1. 4.1.2 4. 4.2.1 b) (All) 4.2.2 (All) 5.3 2. 5.4.1 2. Overview This Quality Manual outlines the scope of the Quality Management System (QMS), its documented procedures, and a description of how these

\ – Software Validation Form 1. Software Information Field Details ID \<ID> Name \<Name> Version \<x.x.x> Location \<url> Processes \ 2. Intended Use and Context Provide a description of the software’s intended purpose and how it is used (e.g., automation,

Regulatory Requirement Document Section ISO 13485:2016, Sections 6.2 and 7.1 Entire Document Overview This SOP outlines procedures for managing personnel within the organization. It details processes for onboarding and offboarding employees, conducting initial and ongoing training, and facilitating feedback between

ISO 13485:2016 Section Document Section 7.4 All Overview This SOP outlines the processes and requirements for purchasing goods and services by the organization. It covers the initial evaluation of suppliers, budget approval, and ongoing supplier oversight. The aim is to

This template is best used within an Excel or Sheets document. Typically, an audit program encompasses all ISO 13485 requirements over a minimum duration of three years. Audit Program \ 2021 – 2024 1. General Information Auditing Period 01/2023 –