Computer System Validation

We can support you with your Lifecycle- Process and Documentation for:

Process Validation/Equipment Qualification and especially Computer System Validations according to ISO 13485 Sections 4.1.6, 7.5.6 and 7.6 and 21 CFR Part 820.70 and 820.75, 21 CFR Part 11, GAMP4, GAMP5, PIC/S, AAMI TIR36, Cybersecurity and General Data Protection Regulation (GDPR)

Medical Devices

Medical Device Software

In-Vitro Diagnostic Devices

Combination Products