Quality and Regulatory Acting as a UK Responsible Person for manufacturers based outside the UK. ENQUIRE

All medical devices sold in the UK market need to be registered with the Medicines and Healthcare Regulatory Agency (MHRA). Manufacturers based outside the UK are required to appoint a UK Responsible Person to carry out specified tasks in relation to the manufacturer’s obligations. The responsibilities of the UK Responsible Person are set out in the UK MDR 2002.

 

With more than 65 years’ combined experience in the UK orthopaedics and spine market, we’re ideally positioned to be your UK Responsible Person, and to support you with the tasks needed to market your medical device here: getting your device certified, ensuring device conformity and registering your device with the MHRA.

 

The service includes:

Document Check

 Registration Check

Audit Support

Vigilance Reporting

Document Check

 Registration Check

Audit Support

Vigilance Reporting

Edna Kurokawa

Quality and Regulatory Officer

 

A highly experienced medical device professional with a large set of skills at quality management systems and regulatory affairs of medical devices and in vitro diagnostic products (IVD), Edna joined the group as Quality and Regulatory Officer in 2020.

 

Edna has a background in production processes, import, distribution and registration processes (Brazil, EUA and Europe) as well as internal audits and validation methods.

Discover More

 

If you would like to speak to our team to discuss your strategy and the services we can provide, please get in touch.

Case Studies

BUY-SIDE M&A Case Study

Medical Device Manufacturer

 

To support our client with their inorganic growth strategy. We were engaged to deliver a pipeline of acquisition targets through identification, introduction and meeting facilitation.