Regulatory Support for Medical Devices
Bringing medical devices to market requires expert navigation of evolving UK and EU frameworks – including MDR, IVDR, CE, and UKCA requirements.
Our team of seasoned regulatory experts brings a wealth of experience and industry knowledge to ensure compliance for your medical device or combination product.
We understand that every project and its requirements are unique, which is why we offer expert commercial, regulatory, and product development support at every stage – helping you bring your medical device to market efficiently and compliantly.
Our medical device regulatory services include:
Regulatory Strategy – Helping you navigate the complexities of US, EU, and UK frameworks, and define the optimal regulatory pathway for your medical device.
Device Classification Strategy – Determining classification, conformity assessment routes, and essential requirements under MDR and IVDR.
EU MDR Navigation – Close monitoring of evolving regulations and liaison with regulatory authorities to ensure full compliance and efficient submissions.
Quality Management System (QMS) Assistance – Supporting the setup of compliant systems to meet regulatory and safety requirements.
Technical File Preparation and Advice – Ensuring complete, clear, and compliant technical documentation for your device.
Notified Body and Agency Interactions – Acting as intermediary with regulatory authorities and notified bodies on your behalf.
Drug–Device Combination Support – Navigating the interface between drug and device regulations, leveraging our cross-sector expertise.
Boyds’ regulatory specialists combine deep understanding of medicinal and device frameworks, enabling seamless compliance for standalone, combination, and advanced medical devices under MDR, IVDR, and UKCA regulations.
Get in touch today to find out how we can help you bring your medical device to market.
Get in touch
If you would like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we will get in touch.