Medical Devices
Sharp Regulatory has experience writing and advising on the content of clinical investigation dossiers and CE Mark dossiers for competent authority and/or Notified Body submission in EU and US FDA PMA and 510Ks. We are also able to arrange meetings with relevant bodies to ensure that you are completely aware of the testing that needs to be completed for your particular device.
Getting in touch
If you would like to have an initial conversation about your requirements please contact Angela ……
Mobile Number: +44 (0)7738 971523
Email: [email protected]