Our clients are companies from the medical device-, pharmaceutical-, biotechnology- and in-vitro diagnostic industries.
Globally active large-, medium- and small enterprises and consultancy firms
We can support with all device related disciplines like project management, quality management- and regulatory affairs services, design control support, design transfer, clinical evaluations, usability engineering/human factors, risk management, etc.
We can build-up or improve your quality management system and make sure you obtain the necessary market authorizations.
Start-ups and entrepreneurs
Start-ups are often research driven and at risk to never really leave this research mode and therefore ending up in endless prototyping with their products. To avoid this, QUAREGIA can support with concepts from the very beginning to systematically develop and industrialize new products towards commercial distribution. Examples are regulatory strategies, fully automated and validated development process' and tool chains, concepts for artificial intelligent systems, cybersecurity concepts, etc.
We are asked by investors (e.g. banks, private equity investors, venture funds) to cover the Regulatory and Quality Management part in their due diligence activities of life science companies.