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UL Solutions delivers ISO 13485 quality management system audits that help medical device manufacturers demonstrate compliance, manage regulatory risk and maintain confidence across the entire product lifecycle.
Our quality management system audit supports organizations seeking ISO 13485 certification and and can be combined with ISO 9001 or MDSAP to reduce duplicate audits and streamline your compliance plan.
Your audit assesses readiness and conformity of documented procedures and processes to ISO 13485 requirements, with clear reporting of any nonconformities and next steps.
To help minimize multiple audits, you can schedule combined ISO 13485 audits with ISO 9001 and/or MDSAP, aligning activities and timelines for efficiency.
We follow a structured, step-by-step approach to verify the medical device quality management system (QMS), evaluate compliance, and maintain certification over time.
When your growth strategy requires broader market acceptance, MDSAP combines ISO 13485 with the regulatory requirements of five jurisdictions (U.S., Canada, Australia, Japan and Brazil), helping reduce the number of separate audits.
In Canada, the MDSAP certificate has replaced the ISO 13485 certificate in the medical device license process; participating authorities leverage MDSAP audit reports in various ways to streamline oversight.
MDSAP audits, conducted by an approved auditing organization like UL Solutions, follow a three‑year cycle (Stage 1, Stage 2, annual surveillance, recertification).
If you’re targeting multiple MDSAP markets, a single QMS certificate can save time, reduce audit fatigue and minimize operational disruption compared to separate audits.
Support your certification program with adjacent services that help verify product safety and performance while navigating global regulatory pathways.
UL Solutions provides medical device performance and safety testing (e.g., EMC, wireless, cybersecurity, biocompatibility) and regulatory support across standards such as IEC 60601, IEC 62304 and ISO 14971. Explore Medical Device Regulatory Testing and Certification to plan an integrated route from testing to market access.
UL Solutions is a UKAS‑accredited Registrar under ISO 17021 offering QMS registration to ISO 13485 and ISO 9001, with all auditors conducting these services employed full‑time by UL Solutions for consistent experiences. Our regulatory auditors are part of 15,000 mission‑driven employees in 40+ countries serving customers in 100+ countries.
UL Solutions does not design QMSs or provide consulting related to systems we certify, maintaining impartiality as an ISO 17000‑series accredited certification body and MDSAP Recognized Auditing Organization.
Get in touch to schedule your ISO 13485 audit or discuss combined options (ISO 9001 and MDSAP) that align to your regulatory roadmap. Our team helps you streamline audits while supporting long‑term compliance.
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This on-demand webinar reviews updates and considerations for U.S. medical device manufacturers ahead of the FDA’s issuance of a Final Rule on QSR 21 CFR Part 820, harmonizing with ISO 13485:2016.
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UL International (UK) Ltd. was recently designated as an Approved Body for medical devices, to support the needs of connected medical device manufacturers seeking market access in Great Britain.
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A QMS audit is an independent assessment of your documented procedures and processes against applicable standards (such as ISO 13485) to system’s readiness and conformity with regulatory and quality requirements.
ISO 13485 is the internationally recognized Quality Management System standard for medical devices, use by organizations throughout the device lifecycle to demonstrate their commitment to product safety, quality, and regulatory compliance.
With UL Solutions, you undergo Stage 1 (readiness) and Stage 2 (certification) audits; after successful registration, you undergo annual surveillance audits and triennial recertification to maintain your certificate. Combined audits (e.g., with ISO 9001 or MDSAP) are available to improve operational efficiency.
Your QMS is the system you implement to meet ISO 13485 and related requirements. MDSAP (Medical Device Single Audit Program) is a regulatory audit program that evaluates your QMS to ISO 13485 plus specific requirements of five authorities (U.S., Canada, Australia, Japan, Brazil), allowing single audit to serve multiple global markets.
Timing varies by organization’s size and complexity. Typically, Stage 2 follows one to six months after Stage 1, with surveillance audits conducted annually and a recertification audit every three years.
No. To protect impartiality, UL Solutions does not design QMSs or provide consulting tied to certification.
During Stage 1, auditors focus on documented procedures (SOPs) and preparedness per ISO 13485 and, when applicable, MDSAP audit criteria. The written findings from this review guide your readiness assessment and help identify any current gaps to be addressed before Stage 2. While UL Solutions does not publish a generic audit checklist, these findings provide a clear framework for the readiness evaluation.
Yes. FDA’s QMSR incorporates ISO 13485:2016 by reference (final rule issued Jan. 31, 2024; effective Feb. 2, 2026). This alignment harmonizes U.S. QMS regulatory expectations with the international ISO 13485 standard.
