Consultancy

We provide consultancy and training in quality management and regulatory compliance:
**ISO 13485 for medical devices and IVDs**: quality systems, technical files, audits and regulatory support.
**EU MDR and IVDR**: technical documentation, quality systems and regulatory requirements.
**UK MDR 2002 and UKCA**: technical documentation and conformity assessment.
**General Product Safety Regulation (EU) 2023/988**: risk assessments, technical files and product safety systems.
**ISO 9001 and ISO 14001**: management systems, documentation, implementation support and audits.
**ISO/IEC 27001, ISO 14971 and IEC 62304**: information security, medical device risk management and medical device software.
We support product development from concept to market. We audit on site and remotely, including certification readiness audits.

Support

Once you have a quality management system or product certification, you need to review and update it regularly to stay compliant.

Our support service gives you more than 28 years of experience. We are available by email, phone or in person. We help you keep up with quality standards, regulatory requirements and technical updates.

As part of this service, we can act as your Authorised Representative and Person Responsible for Regulatory Compliance (PRRC) in the UK, Northern Ireland and the EU, where the rules allow it.

We follow regulatory developments, including Regulation (EU) 2023/988, and guide you through the changes you need to make. This lets you focus on running your business.

Representation

We are your EU, Northern Ireland and UK representative for medical devices and IVDs, from one office in Belfast, Northern Ireland:

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

We keep up with current requirements, so your products stay compliant in the EU, Northern Ireland and the UK.

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

Discuss your device