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UL Solutions is committed to making sure our medical Quality System Registration customers are able to demonstrate compliance with the latest standards and current requirement. UL Solution’s experienced auditors will independently assess your QMS and ensure it meets ISO 13485 requirements. Obtaining ISO 13485 certification from UL Solutions helps you have confidence in the systems which manufacturer your medical devices thanks to a Notified Body with a long-standing reputation. An ISO 13485 certification might give you a competitive advantage over other medical devices manufacturers and increase the confidence of your manufacturing processes.
UL Solutions is a global leader in applied safety science. Our auditors offer expert knowledge in testing, inspection and certification of medical devices and have gone through rigorous training programs and participated in continuous professional development. UL Solutions remains current with existing and emerging international standards through its participation in ISO CASCO 170XX Working Groups, IEC SC62A, IEC SC62D, IEC TC62, CLC TC62, ISO TC210 and MDSAP forums.
As a UKAS-accredited Registrar under ISO 17021, UL Solutions provides QMS registration to multiple programs. Under UKAS, we offer audits to ISO 13485 and combined audits to ISO 13485 and ISO 9001. To help you maximize time and efficiency, we offer combined ISO 13485, ISO 9001 and MDSAP audits UL-UK International Limited is an Approved Body by MHRA against the MDR 2002 (as amended) for IVD devices with expectation of expanding that scope to include medical devices in the near future (Q3 2023). With this new program, we continue to offer combined audits with all of our other offerings thus continuing to minimize the need for multiple audits.
All our auditors are full-time UL Solutions employees providing consistent audit experiences and support throughout the life of your QMS. With UL Solutions as a trusted partner and our worldwide network of technical medical device experts, we help you innovate and navigate complex regulatory requirements.
Our Regulatory auditors and assessors are part of our 15,000 mission-driven employees working in more than 40 countries to serve customers in over 100 countries. The UL Certification Marks serve as a recognized symbol of trust and reflect an unwavering commitment to advancing our safety mission.
