Plan your entire post-market surveillance and benefit from exclusive annexes guiding you in planning and data collection; PMS plan template (.docx) 20 pages + PMS implementation guide (.docx) 47 pages
Write your Periodic Safety Update Report (PSUR) in accordance with MDR 2017/745, benefits from a real medical device examples; PSUR template (.docx) 18 pages + PSUR implementation guide (.docx) 38 pages
Implement a well-known statistical method tailored to the regulatory requirements outlined in the MDR and IVDR regulations. This all-in-one package makes it easy for you to integrate trend reporting into your system with a procedure, an Excel file, and a guide, taking you from theory to practice.
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.
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.
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!
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.