Quality by Design / Process Controls / Design Controls

Risk Management and Usability Engineering



In conclusion: We provide the entire range of cybersecurity services to make your device secure, be compliant with medical device regulations worldwide and therefore ready to submit and launch your product. We can help you with establishing a cybersecurity concept, designing, usability, risk assessing, implementing, testing, documenting/reporting and submitting your device according to medical device regulations worldwide.

Medical Devices

Medical Device Software

In-Vitro Diagnostic Devices

Combination Products