https://www.bspartnership.co.uk/home daily 1.0 2026-09-30 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1575582390727-BIDUZ896PRX56ZCK9CHM/image-asset.jpeg Home https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1575582447029-5NTMIDEM9OX31FK60OS0/image-asset.jpeg Home - “ 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 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1577713309480-WKE1G0UN843ZO9QYHVB5/image-asset.jpeg Home - What we do 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. 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 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1790762037788-W02GCT16C2LKFCFAXCZ5/image-asset.jpeg Home - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1790725394418-LQQCOW1M90HVVTKT4J60/unsplash-image-RlOAwXt2fEA.jpg Home https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1790725451319-MEJLBNHEL2TZ933VNK37/unsplash-image-0lrJo37r6Nk.jpg Home https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1790725786817-V1FFASNPIES5VY9TSH4J/unsplash-image-4F0sg4IS8UI.jpg Home https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1790726581360-EYF6LXL7MGOENPIRW4JS/unsplash-image-CpsTAUPoScw.jpg Home - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.bspartnership.co.uk/consultancy daily 0.75 2026-09-30 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1576704282233-LGCELA773LUOARF12EXZ/image-asset.jpeg Services Provided - 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. https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1589461546244-N7SU9S8QDOLNIQ9S553Y/image-asset.jpeg Services Provided https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1589461663777-0WM8KPTDT40YOIOVDUWR/image-asset.jpeg Services Provided https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1589461774519-V3FPCBOHC9VZX0DLLX0T/image-asset.jpeg Services Provided https://www.bspartnership.co.uk/blog daily 0.75 2026-09-30 https://www.bspartnership.co.uk/blog/connected-medical-devices-and-gdpr-where-the-health-data-goes monthly 0.5 2026-09-30 https://www.bspartnership.co.uk/blog/iso-9001-2026-what-changed monthly 0.5 2026-09-30 https://www.bspartnership.co.uk/blog/eudamed-becomes-mandatory-on-28-may-2026-what-manufacturers-need-to-do-now monthly 0.5 2026-09-30 https://www.bspartnership.co.uk/blog/iso-204172026-what-medical-device-manufacturers-need-to-know 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monthly 0.5 https://www.bspartnership.co.uk/blog/tag/%23EnvironmentalStandards monthly 0.5 https://www.bspartnership.co.uk/new-index daily 0.75 2026-09-30 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1585002680126-FA8PP7IJ04JQBQYVX3AT/image-asset.jpeg Authorised Representative (CE) https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1608199232777-251ZICAFZW6DV8DRXPTN/image-asset.jpeg Authorised Representative (CE) - Person Responsible for Regulatory Compliance (PRRC) All manufacturers and EU authorised representatives must have a PRRC. Manufacturers are required to confirm that their EU authorised representative has appointed a person meeting the PRRC qualifications as outlined in Article 15 of the MDR and IVDR. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its PRRC. MDR and IVDR introduce the new role of the person responsible for regulatory compliance, the PRRC. Manufacturers and authorised representatives are required to appoint a PRRC PRRCs must demonstrate adequate qualifications for this role. Where the organisation is a micro or small business it is possible to outsource the PRRC role to an outside expert. https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1608199391594-V2H4LN92GVQL61P9B7EP/image-asset.jpeg Authorised Representative (CE) - Who can be a PRRC? Article 15(1) of the MDR and the IVDR calls for a person possessing the requisite expertise in the field of medical devices, which is defined as qualifications that are demonstrated by either: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. or: (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. While formal qualification is easily documented with a diploma or certificate, professional experience in medical device regulatory affairs or in quality management systems (referring to experience gained in the EU) must be demonstrated as well. Qualification based on professional experience must be substantiated with documents such as a work contract, organisation chart, training evidence or internal records such as document releases. https://www.bspartnership.co.uk/ukca daily 0.75 2026-09-30 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1608199483912-SDTCEF5UNAOCLGYYWPL7/image-asset.jpeg UKCA https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1608203258977-QXB53XI5NNNXYU3LY5J7/image-asset.jpeg UKCA https://www.bspartnership.co.uk/contact-us daily 0.75 2026-09-29 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1790723703308-TBDG5D7TKIH5QTBVT3X8/unsplash-image-vsFGmjd9Pic.jpg Contact Us - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1790723778014-D1P0KL09NDM4DY42Z6Y3/unsplash-image-qmZUcdwY5bE.jpg Contact Us - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.bspartnership.co.uk/meet-the-team daily 0.75 2026-09-29 https://images.squarespace-cdn.com/content/v1/5de9770843140d198883a71b/1606996231808-3Z8QRGS44ZG1B728EIZ3/0.jpeg Meet the Managing Director https://www.bspartnership.co.uk/our-clients daily 0.75 2026-09-30 https://www.bspartnership.co.uk/euuk-authorised-representative-ltd daily 0.75 2026-09-29 https://www.bspartnership.co.uk/importer-services daily 0.75 2026-09-29 https://www.bspartnership.co.uk/prrc daily 0.75 2026-09-30 https://www.bspartnership.co.uk/store daily 0.75 2023-03-20