We aim to provide a quickly deployed, user-friendly and adaptable electronic QMS that accelerates time to certification and market for medical devices. Simplicity is at the core of our design to ensure that customers are not overwhelmed when introducing an electronic QMS.
Companion QMS 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 software to achieve and maintain certification for their Quality Management Systems. Instead, they were operating expensive and time-consuming paper record printing, ink signature approvals and photocopying for manual distribution. Realising there must be a better option he decided to develop his solution incorporating more than twenty years of regulatory compliance know-how.
Frank has 22 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 80 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.