REPRESENTATION – OVERSIGHT – COMPLIANCE

Experienced regulatory support
for a responsible presence

Entering/remaining in regulated medical markets involves responsibilities that cannot always be managed internally.

UK Responsible Person

Representation for medical manufacturers based outside the UK who require a UK Responsible Person for British markets.

Audit & Certification Readiness

Practical assistance with manufacturer and device registration, regulatory information and ongoing changes to the market.

Flexible Quality Resource

Experienced regulatory compliance support for organisations requiring access to a Person Responsible for Regulatory Compliance.

Bringing your medical devices
to the British market?

Acting on behalf of the manufacturer, the UK Responsible Person provides an important regulatory link between your organisation and the MHRA.

We can support:

  • Acting as your appointed UK Responsible Person
  • MHRA manufacturer and medical device registration
  • Reviewing the information required for registration
  • Holding required regulatory documentation for MHRA inspection

  • Supporting updates following product/company changes

  • Liaising with regarding UK regulatory requirements

Quotes White

Bernie brings a lot of knowledge on quality and regulatory matters. In addition she is a pleasure to work with, bringing enthusiasm and genuine interest. From my experience I would recommend her for supplier audits and internal audits.

Hannah R.

Microsoft AI Product Lead

Quotes White

The independent auditor on our internal audit programme to help us ensure we meet ISO13485 standards and I highly recommend her for such activities. I always learn something from Bernie’s audits and enjoy her positive and supportive approach to compliance;

Sarah M.

Lifescience & Health Business Consultant

Quotes White

It was a pleasure working with Bernie. She made managing quality management systems effortless and could be counted on to host regulatory audits successfully. She was very adept at devising practical solutions to problems.

Mauro C.

Quality & Regulatory Compliance Executive

A responsible relationship, not simply a registration service

A UK Responsible Person acts on behalf of a non-UK manufacturer in relation to specified obligations under the UK medical device regulations. This includes maintaining access to relevant regulatory documentation and supporting communication with the MHRA where necessary.
Working with an experienced quality and regulatory consultant gives manufacturers the additional benefit of practical medical-device expertise behind that representation plus effective communication with your quality and regulatory teams and provide a UK point of contact throughout the relationship.

Team Meeting 1
  • We review your organisation, device portfolio and relevant regulatory information to establish whether we can appropriately support your requirements.
  • Once appointed, we can manage the necessary manufacturer and device registrations with the MHRA and act as your UK regulatory representative.
  • Our involvement does not need to end once registration is complete. We can provide continuing quality and regulatory support as requirements change.