Our Mission

We aim to provide a quickly deployed, user-friendly QMS that accelerates time to certification and market for medical devices. Simplicity is at the core of our design ensuring that customers are not overwhelmed when introducing an electronic QMS

OUR STORY

CompanionQMS is the result of an observation made by founder Frank Enright in his daily work as a quality and regulatory expert. He noted that a significant proportion of medical technology companies were not using compliant software to achieve and maintain certification for their Quality Management Systems. Instead, they were operating legally non-compliant repositories for documents with no valid electronic signature and electronic record controls. Realising there must be a better option he decided to develop his solution incorporating more than thirty years of regulatory compliance know-how.

Founder Frank Enright

Frank has 30 years of experience in MedTech, including senior management and quality roles in four MedTech companies. His consultancy business has provided regulatory and training services to an international client base of over 100 MedTech customers since 2008.

Achievements include successful US and EU regulatory approvals for Pulmonary, Cardiovascular and Patient Monitoring medical devices and successful implementation of certified Quality Management Systems.

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