Bringing systems thinking to
Our Core Medical Device Services
Computer system validation (CSV) is the documented process of assuring that a computer system does exactly what it is designed to do in a consistent and reproducible manner.
Design verification confirms that the design output meets the design input requirements. Each manufacturer establishes and maintains procedures for verifying the device design.
Process Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard.
We can support you during the safety certification of your device. From CE to CSA, fromUL to C-Tick to CCC. We have the knowledge to save you money and time.
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Computer System Validation
Device Safety Certification Support
Ganymede Consulting GmbH decamped in December to the Peter MacCallum cancer hospital in Melbourne for an urgent Computer System Validation of a computer based Quality Management System.
Founder and Principal Engineer
+41 78 778 3114
SOME OF OUR CLIENTS
FDA Inspection Support
FDA foreign inspection comes to an early close. Ganymede Consulting GmbH was on-site providing support to the client both in the back room and answering questions from the inspector (Front room).
A challenge was laid down to Ganymede Consulting GmbH when one of our clients asked us to get a device through the safety certification process in the shortest possible time. We pulled out all the stops and did a world-wide certification in just 6 weeks.
"I have known Dave Clerk professionally and personally for the last several years. David is an outstanding senior level resource and has a great understanding of V&V principles across the Medical Device and Pharmaceutical verticals. Dave has a great eye for detail and is able to react quickly to fluid situations. I recommend David without hesitation."
VP Quality Solutions, Health & Life Sciences at Sidus BioData