We support medical device companies looking to access the UK and EU markets. Whether you need a Legal Manufacturer or regulatory and quality expertise, we can help.
We take on the role of Legal Manufacturer for your medical device, assuming regulatory responsibility for placing it on the UK and EU markets. We own the technical documentation, manage the relationship with notified bodies, and handle all post-market obligations on your behalf.
For companies that already hold or intend to hold their own regulatory responsibilities, we provide expert support across quality management and regulatory compliance.