confinis launches new UK Responsible Person service in UK

confinis will now be offering a full UK Responsible Person service. Following the UK’s departure from the European Union, overseas companies wishing to place a new medical device, IVD or combination product on the UK market must appoint a UK Responsible Person to register such products with the UK regulatory body, the MHRA.

Based at its offices in Cambridge, confinis offers both an efficient Responsible Person service and can draw upon an extensive network of consultants providing expert advice on important aspects of compliance:

  • Regulatory affairs support
  • Quality system development
  • Clinical evaluation
  • Performance evaluation
  • Documentation for clinical trials
  • Design control / product development
  • Auditing
  • Training

Contact us on ukrp@confinis.com.

 

Author: Howard Broadbridge

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