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

• Software Safety and Cybersecurity

• Software Risk Management 

• Artificial Intelligence

• Data Protection

• E2E Software Lifecycle Process (IEC 62304)

• Computer System Validation (CSV)

• Documentation and Preparation for Submission of Medical Device Software

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:

• Software in a Medical Device

• Software as a Medical Device (SaMD)

• Software in a Combination Product

• Mobile Medical Applications

• (Medical) Clouds

• Software used for In Vitro Diagnostics

• Production Equipment

• Hospital Information Systems

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