We have 20 years of Experience with Medical Device Software in all of its facets:

• Software Safety and Cybersecurity

• Artificial Intelligence

• Data Protection

• E2E Software Lifecycle Process (IEC 62304)

• Computer System Validation (CSV)

• Documentation and Submission of Medical Device Software

Software Safety and Cybersecurity, Artificial Intelligence – Preparation for Submission / Certification, Data Protection, Software Lifecycle Process, Software Risk Management, Documentation and Submission of Medical Device Software according to 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