Qualified Person - 'Person responsible for regulatory compliance'

As a QP service provider we support our clients in a transparent, neutral, independent and impartial manner. We maximize value for our clients by identifying and mitigating risks, and by identifying opportunities for business and product improvements.  All our QP personnel are registered and recognized professionals and as such MRM is able to support our clients in complex situations.

A Qualified Person (QP) is somebody who plays a critical role in the Quality Assurance process. A QP's duty is a EU regulation which ensures the company is in compliance in of the EU regulations and requirements by an approved person (the QP).

As your QP we provide

  • Literature Screening
  • Medical Device Vigilance activities i.e.
    • Reporting of Serious Adverse Events (SAE)
    • Field Safety Corrective Action (FSCA) Plan's
    • Periodically Safety Update Reports, and
    • Trend Reports (Articles 61 to 66)
  • Batch releases (IVDR)
  • Clinical Investigations and/or performance evaluations (e.g. interventional clinical studies), to ensure that your medical device is in compliance with the general safety and performance requirements of MDR/IVDR.
  • Auditing as part of Supply Chain Risk Management Control in compliance with the latest European Regulations (EU MDR/IVDR)
  • Preparation and acceptance of Technical and Quality Agreements throughout the Supply Chain.
  • Providing Regulatory and Quality strategic guidance and support for EU product registration

The expectation is that new 'Qualified Person' ('Person responsible for regulatory compliance') requirements - as contained in the MDR and IVDR - will be in effect before the end of year 2015. These requirements will impact the requirements for medical device manufacturers, suppliers, importers, and distributors.

News

  • UKRP-services
      The UK medical device regulatory system is independent of the European Economic Area (EEA). All medical device manufacturers will need to follow UK laws for (in vitro) medical devices, based on the EU regulations EU-MDR 2017/745 and EU-IVDR 2017/746. All non-UK manufacturers must have a UK-based UK Responsible Person…

Whitepaper