Medical Devices

Our global team of medical device professionals works continuously to keep up to date with all the changes to global regulations, quality systems and other requirements for medical devices.  

The new medical devices regulation in Europe.

We are represented on the key EU working groups in the development of guidance documents for many aspects of the new MDR.  We can support our clients now to gap assess product technical files, clinical evaluations, post-market surveillance strategy  and product performance and safety requirements in preparation for product re-certifications against the new MDR.

ISO 13485:2016

We have successfully assisted several clients to transition their QMS to the new ISO 13485:2016 quality management systems certification for medical devices.  Contact us now to see how we can help you gap assess your systems for successful transition.

Post-brexit strategy & responsible person

UK based manufacturers who currently market medical devices, medicines and cosmetics across the European Union will  be required to have an EU-based European representative post-brexit.  With our office in the UK we can act as a Responsible Person for overseas manufacturers under the new UK MDR regulations 2019.