Medical Device Regulatory Consultancy
Our UK based medical device consultants provide expertise on all aspects of the medical device regulatory approval cycle for clients worldwide, both on-site and remotely.
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 within the medical device industry and from working for Notified Bodies, we provide solutions that work for you and your business and are compliant with the regulators, first time.
Please contact us if you require consultancy support on any aspect of developing and taking medical devices through to market.
We can provide support with:
▪ Remediating audit findings
▪ Device development and CE marking
▪ QMS requirements
▪ Technical Documentation
▪ Risk Management
▪ Clinical requirements
▪ Standards compliance
▪ Verification and Validation
▪ Supplier management
▪ Product registration
▪ Recalls and Adverse Event management
▪ Product Design