We listen to understand your needs to deliver professional and tailored solutions
Qualitymanagement & Regulatory
Quality & Regulatory Affairs Services for: Medical Devices Medical Device Software Cybersecurity In Vitro Diagnostic Devices Combination Products
Due Diligence (e.g. company take-overs, investments)
Project Management Services
Safety and (Cyber) Security Risk Management Usability Engineering and Management Interdisciplinary Project Management Remediation Project Management Product Lifecycle Management Software- and Hardware Lifecycle Management Requirements Engineering and Management Configuration and Change Management CAPA Management Manufacturing Process (Production) Management Platform Engineering and Management Waste Management
Medical Device Software
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
QUAREGIA is a Swiss company, founded by Mathias T. Eng. We speak English and German.
QUAREGIA draws on 19 plus years of experience with medical devices, medical device software, in vitro diagnostic devices and combination products.
QUAREGIA is established and very well connected in the medical device-, pharmaceutical-, biotechnology- and diagnostic industries.
plus Companies served
plus Projects completed
plus Years of experience
We don’t believe in Mister or Misses know it all. The life science industry is to broad on specialized disciplines that one company could cover the entire range. To complement our portfolio of services, we collaborate with our partners, each of which supporting with specialized expertise. Together we are strong!
All expertise with just one contractual relationship
Many years of experience and joint know-how
Well rehearsed flexible teams
Special attention we would like to draw on our active participation in educational efforts. QUAREGIA is partner and actively participating
in building up, maintaining and teaching lifescience related modules at the following institutions: