We listen to understand your needs to deliver professional and tailored solutions

Our services

Qualitymanagement & Regulatory

Quality & Regulatory Affairs Services for:
Medical Devices
Medical Device Software
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

About us

Swiss company

QUAREGIA is a Swiss company, founded by Mathias T. Eng. We speak English and German.

Experience

QUAREGIA draws on 17 plus years of experience with medical devices, medical device software, in vitro diagnostic devices and combination products.

Network

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

our partners

Our approach

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!

Your benefit

All expertise with just one contractual relationship

Many years of experience and joint know-how

Well rehearsed flexible teams

Educational partners

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:

Bern University of Applied Sciences

sitem-insel and University of Berne


University of Bern


ARIAQ, Dispositifis médicaux