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A European initiative.

We are shaping the future of technical documentation.
‍Our mission: automate technical documentation, ensure compliance and simplify processes.

As a European initiative, we work closely with manufacturers, auditors and consultants to develop a platform and tools that intelligently understand, verify and automate the content of technical documentation —
for less manual effort, greater compliance, and faster innovation.
Team-NB views on implementation of MDR/IVDR Regulations
October 19, 2025
Insight
Team-NB views on implementation of MDR/IVDR Regulations
Navigating the EU’s MDR and IVDR Landscape: Key Insights from the 10th Notified Bodies Survey
October 19, 2025
Insight
Navigating the EU’s MDR and IVDR Landscape: Key Insights from the 10th Notified Bodies Survey
in collaboration with auditors, manufacturers, and industry experts
Tackling the biggest
Compliance inefficiencies in the medical device industry.
40%
of EU applications examined by the notified bodies are incomplete or contain non-conformities.
13-18
months on average to gain access to the EU market — twice as long as under the Directive.
50%
of medical device manufacturers will significantly reduce their product portfolio.
*Based on data from European Commission, 2025

Solutions developed with industry partners.
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Manufacturer
Manufacturers shorten approval cycles, reduce manual effort and ensure regulatory compliance — with a platform that intelligently automates content.
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Notified bodies
Notified bodies simplify and accelerate testing processes through consistent, digitized technical documentation.
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Consultancies
Consulting firms optimize their internal processes and ensure consistent documentation quality — with a platform that provides customers with digital, efficient and consistent regulatory services.
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