Technical Documentation File template, compliant with MDR 2017/745. Seamlessly aligned with Annex II, it ensures clarity, completeness, and compliance in each section. Tailored immersion with "HealthGuard BPX-2000" device blueprint. Expert-crafted, time-saving, and success leading.

Access a complete framework/template for documenting your GSPRs in accordance with Annex I of MDR 2017/745. For each GSPR: access a list of standards, a list of expected documents and a pre-written methodology. GSPRs are the basis for documenting your medical device's compliance with MDR 2017/745. Use this template as a guide from the start of your project. 77 pages, available for immediate download

Our comprehensive checklist provides you with all the mandatory regulatory requirements for medical device manufacturers. Not only does it outline these requirements, but it also offers two categories that will help you effectively implement them. For each requirement, we provide a method that explains how to incorporate it into your system, complete with concrete examples

This guide reviews the general, pre-market and post-market requirements for a medical device manufacturer aiming to market and maintain its device according to EU MDR 2017/745.

This guide provides 20 clear recommendations for writing Instructions for Use (IFU) for medical devices in compliance with MDR 2017/745 and IVDR 2017/746. It focuses on making IFUs easy to understand, concise, and user-friendly, covering topics such as formatting, writing style, and structuring information effectively. Download it to improve the clarity and usability of your IFU.

This guide provides a clear structure for your technical documentation, including all the sections required by Regulation (EU) 2017/745 (MDR). You will find: - 5 best practices for compiling your technical documentation, - A roadmap for organising your TD, - And other useful tips to optimise your compilation process. Download it to improve the preparation of your technical documentation.

Take advantage of the opportunity to explore the first 10 pages of our template, a meticulously designed resource to assist you in creating your customized technical documentation.

With this checklist, you'll have access to all the checkpoints necessary to create technical documentation that aligns with Annex II of MDR 2017/745.

This strategic guide contains 20 questions to help you synchronise your risk management, clinical evaluation and post-market surveillance processes.

Here's a mini-guide that includes the 7 things I wish I knew during my first submission of the technical documentation for a medical device! Some may seem obvious, others less so. Download this guide to avoid non-conformities in your technical documentation!

Comprehensive guide on how to formulate the clinical development plan, which is to be appended to your clinical evaluation plan for enhanced comprehension.

You will find a list of Regulatory Authorities in Europe to conduct your regulatory monitoring and carry out your pharmacovigilance or materiovigilance in the concerned countries. The list will be updated progressively. Last update: 13/11/2023.