We are an independent compliance consulting company delivering software solutions for medical devices and apps in the health and pharmaceutical sectors
Independent compliance consulting to software as a medical device and medical apps in health and pharma sector
Gap analysis between existing EU Medical Device Directives and new EU Medical Device Regulations.
Gap analysis against ISO 9001, ISO 27001, ISO 62304, ISO 14791
Develop a Audit Management Schedule and Program
Conduct Internal Audits
Develop bespoke Quality Management Systems (QMS)
Preparation of the medical device Technical Files/Device Master Records for Notified Body audit (CE-mark) or FDA inspection
Medical device hazard analysis and risk management
Unit/Integration/Acceptance testing solutions
Manual/Automated test specification and test execution
Develop Test Management Strategy
Integration with the Continuous Integration Continuous Delivery pipeline CI/CD
Conduct Data Governance & Data Quality Gap analysis
Information governance and data protection compliance strategy
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.
