Neil Dahiya

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 –

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

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

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

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

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

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.

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.