Are you in need of a steadfast partner to support you in navigating the intricate regulatory requirements for Medical Technologies in the UK?
With high knowledge and understanding of the EU and UK regulations, their differences and synergies, at Asphalion we can assist you on establishing the best regulatory strategy considering the unique challenges and opportunities of the UK market.
How can we help you?
- Responsiveness to any request and/or inspection from MHRA
- Support for the Registration of Medical Devices with the MHRA
- Regulatory Intelligence to monitor any change in local legislation
- Management of incidents and/or complaints
- Notification of incidents and/or complaints to MHRA
- Support for the UKCA approval for new and CE certified medical devices
Check out all the services we can offer you and how we can adapt them to your project: UK Responsible Person
For further information you can contact us at: [email protected]
