Computer System Validation
Computer System Validation
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We can support you with your Lifecycle- Process and Documentation for:
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 Devices
Medical Device Software
Medical Device Software
In-Vitro Diagnostic Devices
In-Vitro Diagnostic Devices
Combination Products
Combination Products
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