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. 📉
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. 🤔
The solution lies in building the Technical Documentation (TD) in a form that the notified bodies expect. This approach offers significant benefits:
The entire process can be seamlessly automated with digital solutions like meddevo eTD, enhancing efficiency and aligning with the industry's digitalization trend.
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. 🚀