Regulatory processes must become smarter.

Higher requirements do not simply mean a higher headcount. 
My passion is the digitalization of RA, QA and R&D.  
As a result, development, placing on the market and post market surveillance are becoming more cost-effective and even better.

1. Lower your costs 
2. Gain your compliance

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My passion

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MDR Implementation

EU Medical Device Regulation Implementation Roadmap and a smart approach. 

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Technical Documentation

Lean documentation according MDR and MDD.

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Digitalization

Lower costs and gain compliance. 
Digitalizing RA, QA and R&D.

 

Medical Device Content Management

With the manufacturer in mind to challenge the EU-MDR. 
Digitalize your technical documentation!