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Welcome to:

B.S. PARTNERSHIP

We are a UK and Northern Ireland consultancy for quality and regulatory affairs (RA/QA). Since 1997, we have provided support and consultancy services.

  • Authorised Representative for General Product Safety Regulation (GPSR)

  • Quality and Regulatory Support for the Life-Science, Medical Device, and In-Vitro Diagnostic Sectors.

  • Act as an EU and Northern Ireland CE Authorised Representative for medical devices and in vitro diagnostics.

  • UKCA Rep in the UK

  • Serve as your UK and EU Regulatory Compliance Responsible Person.

  • Serve as your importer in the EU, Northern Ireland and the UK, following the MDR and IVDR regulations.

  • UK, Northern Ireland and EU Authorised Representative and Importer for other products and devices.

 
 

What we do

BS Partnership is a quality and regulatory affairs consultancy for medical device, in vitro diagnostic and life-science companies. Jonathan Phillips has been Managing Director since 1997. 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.

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

 

Our Mission…

“Our goal is to provide simple, no-nonsense advice at a reasonable price.”

Since 1997, under the leadership of Jonathan Phillips, we have supported organisations with consultancy and have helped more than 100 of them to certify and register their products and quality management systems.

Why clients stay with us

  • Considerable experience.

  • Your interests come first.

  • Realistic expectations, agreed from the outset.

  • Prompt responses.

  • If we cannot answer a question, we will find the answer or refer you to someone who can.

  • Fair prices.

 

“

BS Partnership has helped us develop and continually improve our fulfilment of the standard throughout software and staff changes, and relocation. We anticipate that we will still be using them in another 10 years time!

— Cambio Ltd