About Us

We are an independent compliance consulting company delivering software solutions for medical devices and apps in the health and pharmaceutical sectors

Our Services

Independent compliance consulting to software as a medical device and medical apps in health and pharma sector

Medical Device Software

Risk Management (ISO 14971)

Software Development (IEC 62307, FDA)

Technical File / Dossier (CE Marking, FDA submission)

GxP Service

Software Development (GAMP5)

Quality Management Systems (QMS)

Regulatory Strategy

Mock Audits / Gap analysis

ISO 9001

ISO 27001

ISO 13485

Integrated Management Systems

Other Services

Outsource the Induction and Training Process

Software Testing

Software Development

Our Team

Our aim is to help software testers and quality engineers to work more efficiently.
We have two locations to serve our customers within Greece and UK. We are located in Thessaloniki, Greece and Oxford, UK since 2019, occupying a small team of software engineers who love to automate.

Evangelos Mantadakis

Evangelos Mantadakis

Manager