We know what is expected from regulators, but more importantly how to make that work within your company in an efficient way.

An expert team of

Medical Device Consultants.

Solutions that work first time. Every time.

Consultancy

We know what is expected from regulators, but more importantly how to make that work within your company in an efficient way.

Not only can we conduct an audit with the scrutiny from a high-quality audit, as consultants we help you remediate the finding.

Auditing

Not only can we conduct an audit with the scrutiny from a high-quality audit, as consultants we help you remediate the finding.

QMS

Our QMS auditing background means we can implement or improve your quality management system in line with best practices.

Training

Classroom, eLearning and virtual courses. We have a wide range of training solutions to meet your requirements.

Who are we?

We are a team of experienced QA/RA professionals, working in the medical device industry for both manufacturers and notified bodies.

We routinely train and provide consultancy services to the top medical device manufacturers around the globe and have authored the highly rated ‘MDR Guidebook’ to assist manufacturers in complying with the EU MDR.

Our expert team has been widely recognised and voted the 'Best-In-Class' Medical Device Regulatory Consultancy company of 2020 by MedTech Outlook magazine.

With our experience training both notified bodies and competent authorities, we can ensure our consultancy delivers solutions that work first time, every time.