Consultancy

We provide consultancy and training in quality management and regulatory compliance, including:
ISO 13485 for medical devices and IVDs - quality systems, technical files, audits, regulatory support
MDR and IVDR transitions - technical documentation, quality systems, regulatory requirements
GPSR compliance - risk assessments, technical files, product safety systems
ISO 9001, ISO 14001, and ISO 45001 - management systems, documentation, implementation support, audits
We support product development from concept to market, with comprehensive technical documentation services and both on-site and remote audits for certification readiness.

Q-Share

Quality and Regulatory Support Once you have established your Quality Management System or obtained Product Certification, it is crucial to regularly review and update the information to ensure ongoing compliance.

Our 'Q-Share' service provides expert support and over 25 years of experience to assist you in this process. We are available via email, phone, or in-person meetings to help you stay current with the latest quality standards, regulatory requirements, and technical updates.

As part of our Q-Share service, we can act as your 'Authorised Representative' and 'Person Responsible for Regulatory Compliance' in both the UK and EU, as required by the Medical Devices Directive (MDD), In Vitro Diagnostic Medical Devices Directive (IVDD), Medical Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), and the new EU Regulation on General Product Safety (Regulation (EU) 2023/988).

We stay up-to-date on the latest regulatory developments, such as Regulation (EU) 2023/988, to ensure your products and quality systems remain compliant. We can guide you through any necessary updates or changes to align with new safety requirements, traceability obligations, and market surveillance measures introduced by this regulation.

With Q-Share, you can have confidence that your quality and regulatory matters are in expert hands, allowing you to focus on your core business operations.

CE Marking, UKCA Marking, and Authorised Representative Services

With over 15 years of experience as a CE Authorised Representative for medical devices and IVDs, we now offer expanded services for both CE and UKCA marking:

EU and UK Authorised Representative
EU and UK Person Responsible for Regulatory Compliance (PRRC)
EU and UK Importer
Regulatory guidance for MDR, IVDR, and UK MDR 2002
Support for compliance with Regulation (EU) 2023/988 on general product safety

Our Northern Ireland office allows us to efficiently serve as your representative in both markets. We stay current on the latest requirements to ensure your products maintain compliance in the EU and UK.

Details of CE Requirements can be found here and UKCA Requirements here.