Neil Dahiya

This table aligns the ISO 13485:2016 requirements by section with the corresponding documents. The document titles listed in the “Fulfilled in Document” column are based on FdaToday templates. If you use a different system for naming documents, feel free to […]

This plan outlines product-specific post-market surveillance activities. The general procedures for conducting post-market surveillance are described in the SOP Post-Market Surveillance, with outputs documented in the Post-Market Surveillance Report or the Periodic Safety Update Report. Regulatory References: EU Regulation 2017/745

Regulatory Requirement Document Section MDR Annex I (General Safety and Performance Requirements), Annex IV (EU Declaration of Conformity), Art. 27, 29, 31 (UDI / Eudamed) All MPDG §8, §96, §97 All ISO 13485:2015, Sections 4.2.3 All Overview This SOP outlines

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,