Considering the sometimes complex assessments of medical device products, we can review your products and advise as to the appropriate legislation to cover different devices in different markets, as we have extensive experience working with a range of device types and classifications.

We can support, advise and carry out the following;

• Guide and assist with data requirements, regulatory activities/applications and liaise with the appropriate regulatory bodies to ensure, where needed, that medical devices are approved by Notified Bodies.
• Advise on classification of your device and the most appropriate and efficient route to market.
• Preparation of applications for a change of classification due to a change in the product or the legislation
• We have experience in developing and implementing quality systems to support ISO 13485 and producing appropriate Technical Files and Clinical Evaluation Reports in support of CE or UKCA marking within all classification levels.
• Medical Device market surveillance, including Incident Reports and Field Safety Corrective Actions.

Current Medical Device requirements to move from MDD to MDR is something that we have built up a lot of experience with in the last number of years and are confident we can provide you with a quick and straightforward path for the transfer.

In the UK where UKCA marking came into force post Brexit, we can assist with approvals under the current and new UK MDR which is expected to be implemented in July 2025.