About Us

We are an independent compliance consulting to software as a medical device and medical apps in health and pharma sector

Our Services

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

Gap analysis and Audits

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 Regulatory Strategy

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

Software Quality Assurance

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

Data Governance & Data Quality

Conduct Data Governance & Data Quality Gap analysis

Information governance and data protection compliance strategy

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