What's New

8 tips for producing effective MDR Technical Documentation

Posted on by Congenius

Producing effective Technical Documentation provides manufacturers with their own central information source regarding their medical device. Accurate Technical Documentation can also reduce the review time spent by notified bodies and make an auditor’s job significantly easier.

Given that Technical Documentation requirements under the Medical Device Regulation (EU) 2017/745 (EU MDR) are more extensive than under the Medical Device Directive (MDD), we have produced an easy-to-read fact sheet that provides 8 useful tips on how to produce effective MDR Technical Documentation, to help facilitate a smooth journey toward the delivery and registration of your medical device.

You can access the fact sheet below by clicking on the “Download” button. And for more resources in the Regulatory field, take a look here.

Related News & Knowledge

×

Get in touch

If you have a challenge that you think we could help with, please feel free to get in touch by filling out our contact form or by giving us a call. We look forward to speaking with you!

Congenius AG
Riedstrasse 1
CH-8953 Dietikon

e: info@congenius.ch
t: +41 44 741 04 04

    ×

    Subscribe to our
    monthly knowledge update

    Stay informed and up to date with the latest industry news delivered direct to your inbox. You can tailor your preferences to prioritise what you'd like to hear about each month; be it MedTech news headlines, fact sheet resources on the latest regulations or longer articles covering timely topics across the wider MedTech industry.