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The growing complexity of medical devices and laboratory equipment requires more advanced testing to evaluate safety, performance and compliance with regulatory requirements. This is critical for safer and more effective patient care.
Our medical device testing offerings for performance and safety are designed to help medical device and laboratory equipment manufacturers demonstrate compliance with relevant standards and requirements. Regulators update their requirements frequently, while the healthcare sector strives to adapt to connected and evolving technologies that impact product safety and performance.
Our deep technical expertise allows us to offer you the right medical equipment testing approach to help you demonstrate the safety and performance of your products. Work with us to stay current with evolving standards, regulations and directives.
Find out more in our brochure
Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory and clinical expertise to help you to navigate your medical device safety testing needs, manage regulatory challenges and bring safer products to market faster.
Our comprehensive suite of medical device testing and certification services includes end-product testing, certification, validation (electromagnetic compatibility (EMC), wireless, safety, interoperability, cybersecurity, biocompatibility) and Global Market Access.
Medical Devices – Part 1: Application of Usability Engineering to Medical Devices
Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements – Part 1: General Requirements
Electrical Equipment for Measurement, Control and Laboratory Use – EMC requirements – Part 2-6: Particular Requirements – In Vitro Diagnostic (IVD) Medical Equipment
AAMI EC12, Disposable ECG Electrodes
ASTM E1112, Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
CE compliance – EU Medical Device Directive (MDD), Medical Devices Regulation (MDR), In-Vitro Diagnostic Medical Devices Directive (IVDD) and In Vitro Diagnostic Medical Devices Regulation (IVDR) certifications
Quality management system (QMS) registration and certification for medical device manufacturers include ISO 13485 and ISO 9001
ISO 14971, Medical Devices – Application of Risk Management to Medical Devices
Our testing and compliance engineers work closely with standards committees to stay up-to-date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC). UL Solutions has several U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA)-accredited testing laboratories in the U.S., Japan and Italy.
The advantages of choosing UL Solutions for medical device testing are many. Here are some of the top reasons medical device manufacturers choose us for their medical testing needs.
Case study
“Throughout the entire process, UL Solutions’ team demonstrated great attention to detail and provided us with prompt support whenever we had doubts or uncertainties,” said Edyta Kocyk, founder and president, Sidly.
"Stages is useful in getting people together, harmonizing our processes and identifying ways for our engineers to work as optimally as possible."
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A complete offering of third-party regulatory services for medical device manufacturers.
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.
We have expanded our service offering to include IVDR certification, supporting in vitro diagnostic medical device (IVD) manufacturers to streamline market access to the European Union.
From AI diagnostics to circular economy principles, explore how upcoming trends in medical device regulation are shaping the industry with expert Pamela Gwynn.
Learn how medical artificial intelligence (AI) differs from traditional software, including its safety‑critical complexity and regulatory challenges.
The U.S. Food and Drug Administration voluntary ASCA program is designed to improve the premarket review process. Join UL Solutions’ and FDA experts to gain insights into its goals and benefits.
Our expert provides insights into the preparation process for MDSAP audits for medical device manufacturers. Read our article to learn about best practices to meet compliance requirements.
Successfully introducing on the market an advanced medical wearable device: Sidly case study.
The webinar discusses how stakeholders in the healthcare industry can address today’s top cybersecurity threats.
The market for home healthcare is growing as service delivery shifts from clinical to home settings. Manufacturers face challenges in supplying equipment that is both more effective and safer.
In this UL Solutions Insight article, we provide an overview of the recall process applicable to medical devices and review the state of medical device recalls.
This on-demand webinar discusses the importance of the total product lifecycle in managing cybersecurity of medical devices, including post-market issues like their end-of-life, end-of-support, decommissioning, and disposal.
The Medical Device Single Audit Program (MDSAP) streamlines the regulatory process for medical device manufacturers by allowing a single audit to satisfy quality management system (QMS) requirements of multiple regulatory authorities.
The In Vitro Diagnostic Regulation (IVDR) continues to reshape the regulatory landscape in the EU, and 2025 marks a key year for manufacturers.
Amendment 524B of the FD&C Act sets new U.S. FDA cybersecurity rules for medical devices. UL Solutions provides expert support to help manufacturers meet these requirements.
Medical device penetration testing is used for more than cybersecurity now. It can address software quality, interoperability and artificial intelligence (AI) risks.
Join our experts to further your understanding of the impacts of AI on the development of medical devices.
