Learn how to create a process for your QMS step by step, according to ISO 13485. This short guide will help you to properly document your processes in your quality management system.

In this short guide, you'll find 9 post-market surveillance concepts you need to know in order to analyse your data and use it correctly in the lifecycle of your device. Having data is good, knowing how to use it is better!

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.

Discover clear SWOT analysis guidance tailored to your QMS, effective strategies to boost compliance and product quality, expert tips for KPI management, and inspiring case studies to guide your quality management journey.

In this practical guide, find advice for compiling your technical documentation for a regulatory submission to your notified body. A quick guide to read that will help you better approach this key stage in the life of your medical device. The PDF should be opened with your default internet browser in order to correctly display the fonts in the guide.

Access a comprehensive framework for building your technical documentation in accordance with the principles of MDR 2017/745.

In this short visual guide you will find out how to approach the concept of pro-activity in your post-market surveillance process according to MDR 2017/745, as well as a big picture of all the data required in post-market surveillance.

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.

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!

This guide will help you review all relevant regulatory requirements concerning post-market surveillance as outlined in EU MDR 2017/745. Understand the regulatory context and the necessary documentation in just a few pages. Also, benefit from exclusive tips to enhance your process.

This guide provides a clear, visual breakdown of Risk Management for medical devices in line with ISO 14971. It simplifies core concepts like hazard, risk, and residual risk using practical examples and illustrations (yes, with sharks). → Understand how risk is built (P1, P2, severity...) → Learn how to control and document it, risk acceptability concept.. 35 pages. 4 Part. Instant download

How to Integrate Risk Management Activities in Design & Development? This short guide, illustrated with concrete diagrams, will help you quickly understand how to place risk management at the heart of your Design & Development activities.

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

How to write an effective procedure ? In this guide you'll find: The place of the procedure in document management and in a process; Where to start?; Strategies for writing a procedure; How to be clear and relevant; How to structure your procedure; My writing tips

7 Mistakes to avoid in your Post-Market Surveillance process that will surely lead to Non-Conformities Here's a guide that will save you from repeating these 7 common mistakes we've encountered with some manufacturers, during workshops, or when reviewing PSUR/PMS plans. A 5-minute read that will save you hours of correcting potential non-conformities.

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 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 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.

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