CE Marking

We have worked with numerous SMEs and Start Ups to develop their Quality Management System (QMS), Technical File and Risk Management Documentation to help them attain a CE Mark for their new medical device(s) in both a timely and cost-effective manner.

We have experience of working with all classes of medical device (Class I, IIa, IIb and III) across a wide range of product types.

Software as a Medical Device (SaMD) is a specialism as we have helped numerous clients classify the device (under Rule 11 of the new Medical Device Regulation) and prepare the relevant documentation to ensure compliance with the new MDR, IEC 62304 and ISO 27001.

Call us now 07933 545 591

Contact Us

UK Address. 5 Ashley Road, Clevedon, BS21 7UX

EU Stratton House, Bishopstown Road, Cork, Ireland

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