1. General Information This document outlines the relevant standards, norms, and regulations applicable to the medical device. It is periodically updated according to the SOP for Regulation Updates, ensuring that changes in requirements are evaluated. Regulatory references: ISO 13485:2016 Sections […]
Template: List of Regulatory Requirements Read More »
ISO 13485:2016 Section Document Section 8.5.1 All 8.5.2 All 8.5.3 All Overview This SOP outlines the procedures for initiating, implementing, and tracking CAPAs. Process Owner \ Key Performance Indicators \ Process Steps 1. CAPA Inputs CAPAs may be initiated due
Template: SOP Corrective and Preventive Action (CAPA) Read More »
NOTE #1: This template is designed to provide a structural outline. It is recommended to use Excel or Sheets instead of MS Word for optimal use. NOTE #2: Consider each sub-section below as a separate tab in your spreadsheet. General
Template: Management Review Report Read More »
Purpose / Scope This checklist must be completed for any initial evaluation of a supplier or when re-evaluating a blocked supplier for potential approval. 1. General Supplier Details Company Name FdaToday GmbH Address: c/o Factory Works GmbHSample Str. 2120113 SampleStatePoland
Template: Supplier Checklist Read More »
Regulatory Requirement Document Section ISO 13485:2016 Sections 5.6.2 and 7.3.3 All Summary This SOP outlines the procedure for identifying regulatory changes that apply to the organization as a manufacturer or to its market products. The process is designed to ensure
Template: SOP Update of Regulations Read More »
1. General Details Training Name Training Date Method of Training Trainer Training Content 2. Attendees No. Full Name Signature Completion Status 1 2 3. Verification The training supervisor hereby confirms that all participants listed above have successfully completed the training.
Template: Training Record Read More »
ISO 13485:2016 Section Document Section 4.2.4 All 4.2.5 All Overview This SOP outlines the procedures for managing documents and records within the organization. It ensures clarity on document structure, states during the document lifecycle, and facilitates traceability of document changes.
Template: SOP Document and Record Control Read More »
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
Template: CAPA List Read More »
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
Template: Software List Read More »
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
Template: SOP Internal Audit Read More »