B.S. Partnership is a quality and regulatory affairs consultancy for medical device, in vitro diagnostic and life-science companies. Jonathan Phillips has been Managing Director of B.S. Partnership since 1997 and is a director of EU-UK Authorised Representative Ltd. He is a lead auditor with more than 28 years of experience.
Some of our clients have been with us since 1997. We support most of our clients on an ongoing basis, with remote and on-site consultancy and audits.
Quality management. We set up ISO 13485 and ISO 9001 systems, provide training, and support you through certification. We also cover ISO 14001, ISO/IEC 27001, ISO 14971 and IEC 62304, and we help with CE and UKCA technical files.
Representation. Through our Belfast subsidiary, EU-UK Authorised Representative Limited, we act as EU Authorised Representative (for the EU and Northern Ireland) and UK Responsible Person for medical devices and in vitro diagnostics. This covers EU MDR 2017/745, EU IVDR 2017/746 and UK MDR 2002. We also act as your importer, and as Authorised Representative under the General Product Safety Regulation (EU) 2023/988. We can also provide a Person Responsible for Regulatory Compliance (PRRC) under Article 15.
Where we work. We are based in Cardiff. Our clients are in Canada, China, Denmark, England, France, Germany, India, New Zealand, Scotland, Sweden, the USA and Wales.
If you have any questions about our services, please contact us.
Best Wishes, Jonathan Phillips
Notified bodies and data protection officers ask different questions of the same device. Where the health data sits, and what to do about it.