Medical Device Software

We have 50+ years of Experience with Medical Device Software in all of its facets:

all according to corresponding regulations, standards and guidelines such as MDR, IVDR, 21 CFR Part 820, IEC 62304, ISO 14971, IEC 80001-X, IEC 80002-X, IEC 82304-X, AAMI TIR32, AAMI TIR57, GPSV, FDA Software and Cybersecurity Guidelines and General Data Protection Regulation (GDPR) for:

For an introduction to defining the regulatory pathways for medical device software, please refer to our most recent blog post

Medical Devices

Medical Device Software

In-Vitro Diagnostic Devices

Combination Products