Let's imagine,
in our regulated MedTech industry we ...
- have a clear regulatory language that enables easier interpretation of regulatory terms in regulatory documents
- can easily digitalize regulatory processes in order to speed up creation and review of the technical documentation
- can increase efficiency of medical device development, market access and thus reduce costs in the overall medtech ecosystem
- enable more and faster innovation and thus better patient care
… and ensure that the European MedTech industry is well positioned for the age of digitalization and global competition.
Our Mission
We are a nonprofit organization with stakeholders from the MedTech industry and convinced, that an open source data model for content of the technical documentation for medical devices can accelerate digitalization and innovation in our industry. Due to the high complexity of content and variety of involved disciplines, such a data model can only be developed by the MedTech community for the MedTech community: That is what we do.
Our goals: A clear regulatory language and foundation for an efficient digitalization – for medical device manufacturers, notified bodies and other stakeholders. This is our contribution to better patient care in Europe.
Status quo
The pace of innovation in Europe has slowed massively. New medical devices are approved more quickly in the USA and other countries.
Challenges
Creation and ongoing maintenance of technical documentation files in the post-market phase are complex and time consuming.
Digitalization
Digitalized regulatory lifecycle processes, technical documentation and submission procedures can immensely increase efficiency.
Benefits
A unified data model supports the standardization of processes, content, data exchange and is the foundation for digitalization.
MDKU Medical Device Knowledge Units e.V.
Am Weichselgarten 7
91058 Erlangen
Germany