5 Benefits Listening to your Notified Body

Michael M. Kania
August 24, 2023
Medical Device Regulation

In the medical device industry, technical documentation is paramount. A recent survey, however, uncovers a concerning fact: 80% of notified bodies report that half (50%!!!)of the required information is missing in the submitted documents. 📉

What's Happening?

With the MDR draft in existence for over 11 years, one must ask: Why is there still such a high error rate?
This question was recently debated among RA experts. Manufacturers seem to be reinventing the wheel, reinventing document and folder structures that may suit their company but lead to confusion for the readers. 🤔

A Step Towards Clarity

The solution lies in building the Technical Documentation (TD) in a form that the notified bodies expect. This approach offers significant benefits:

  1. No Need to Invent from Scratch: Utilize existing structures.
  2. Visibility of Missing Elements: Easily identify what's lacking.
  3. Familiarity for Notified Bodies: They don't have to re-learn to find and understand your data.
  4. Speed and Efficiency: Faster process with fewer questions.
  5. Cost Savings: Streamline the process and save money. 💰

Future with Automation and Digitalization

The entire process can be seamlessly automated with digital solutions like meddevo eTD, enhancing efficiency and aligning with the industry's digitalization trend.

Join Us in Revolutionizing Technical Documentation

At, we're not just talking about the future; we're building it. We are developing a solution to submit technical documentation to the notified body completely digitally. This innovation is set to transform the way the industry operates, ensuring accuracy, compliance, and efficiency.

Feel free to contact me to explore how our cutting-edge solutions can revolutionize your technical documentation process. Together, we can bridge the gap and lead the medical device industry into a new era of clarity. 🚀

No credit card required
See the DEMO
Discovery Call & Get access
Take a look at the most sophisticated solution developed specifically for medical devices and IVD.
1. Discovery Call |  2. DEMO  |  3. Workspace Setup
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.