Tailored support to secure UKCA or CE-marking for your medical devices.
MDR & MDCG Chatbot
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Do you need support with your medical device approval strategy?
Some of our services
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UK & EU MDR Consulting
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Clinical Evaluation
CEP & CER writing services with success across 250+ submissions spanning all risk classes.
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IVDR Consulting
Ensure your in vitro diagnostic medical devices gain first-time IVDR approval.
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SaMD Accelerated Approval
Software as a Medical Device certification where time-to-market is existential.
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US to EU Market Access
We'll leverage your device's existing FDA 510(k) clearance to accelerate UK & European certification.
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QMS Jumpstart
An all-in-one Quality Management System platform will ensure you meet ISO 13485 requirements.
Free MDR Compliance Checker Evaluate your regulatory strategy against EU MDR requirements for all your medical devices
Resources for Medical Device Regulation
Get guidance on medical device regulation through exclusive resources written by our subject matter experts