Market Access for Health and Life Sciences

Our expertise and software help customers streamline regulatory affairs and compliance. Our testing capabilities help demonstrate medical product safety and performance*.

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Leverage our market access offerings

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Market access challenges for industry innovators

Product safety, performance and quality paradigms are shifting as medical technology advances, devices become more interoperable and digital health products proliferate. These trends have broadened the scope of regulatory compliance and risk management, making market access more challenging for health and life sciences companies. It’s critical to adopt product development processes that support rapid innovation, and also meet usability, safety and global regulations and standards*.

Proliferation of digital health technologies

Expertise gap in user-centric product development

Complex regulatory climate

35%

Of U.S. adults use wearable healthcare devices at least once per day.[1]

14%

Rise in medical device recalls in 2024, driven by stricter regulations and enforcement.[2]

1.77 billion

People are expected to start using digital health products by 2029.[3]

34%

Of medical product recalls are due to poor design controls.[4]

We help industry innovators access highly regulated markets with confidence

Close product development expertise gaps

Have compliant product development with human factors engineering (HFE) consulting and software*.

Demonstrate safety and verify performance

Comply with market standards, regulations and best practices with our rigorous testing and certification.

Automate and streamline regulatory affairs

Ease medical market access with global regulatory expertise and software*.

Meet product usability, safety and regulatory requirements

Product and process development

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UL Solutions offers human factors engineering advisory and software support to help product developers and R&D professionals lacking internal resources and expertise to develop safer, more effective and more usable medical products*.

Testing and certification

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Regulatory readiness and compliance

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Product and Process Development for Health and Life Sciences

UL Solutions offers human factors engineering advisory and software support to help product developers and R&D professionals lacking internal resources and expertise to develop safer, more effective and more usable medical products*.

Testing and certification for health and life sciences

Medical Device Performance and Safety Testing

We conduct independent, rigorous testing and certification of medical devices to help manufacturers demonstrate safety and performance claims according to regulatory requirements and industry standards. 

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Quality Management System Audit Service

We provide independent assessment of health and life sciences companies’ QMSs to verify compliance to the ISO 13485 standard for medical device quality management systems. ISO 13485 certification is required by regulators in many markets.

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SaMD and Health Software Certification

We offer testing and certification for software as a medical device (SaMD) according to industry standards including IEC 82304-1, IEC 60601-1 part 14 and IEC 62304, which can help demonstrate SaMD safety and quality.

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Software and consulting services for medical market access

Medical Device and IVD Regulatory Affairs and Quality Consulting

The Emergo by UL team of regulatory affairs experts helps medical device and IVD companies achieve their market access goals and maintain post market compliance in more than 20 countries*.

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Human Factors Engineering and Usability Consulting

Our Human Factors Research & Design team provides HFE and usability support, including user research and analysis, design, usability testing and training*.

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Regulatory Affairs Management Suite (RAMS^®)

Emergo by UL offers the Regulatory Affairs Management Suite (RAMS) SaaS platform, enabling customers to automate regulatory affairs processes and leverage our regulatory intelligence across multiple markets*.

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Meet our experts

“A well-thought-out regulatory strategy can enable innovation, streamline market access and position your business for sustained growth.”

Evangeline Loh

Senior Manager, Quality & Regulatory Affairs

“Together, we create solutions that help Medtech innovators ensure essential technologies reach the market safely and effectively.”

Pamela K. Gwynn

Principal Engineer, Consumer, Medical & Information Technologies

Related market access resources

Understanding Human Factor Engineering in Medical Products

Our eBook explains how access to best practices can help guide major human factors engineering stages of medical product development.

Global Regulatory Compliance for Medical Devices

Learn more about taking a strategic approach to achieve regulatory approval in medical device markets around the world.

US Market Access for Medical Devices: FDA and ASCA Program 2024

This on-demand webinar, hosted in collaboration with the U.S. FDA, provides insights into the ASCA  program: its goals, deliverables and benefits.

Revolutionizing UX with Smith+Nephew myTSF™ App

Learn how Emergo by UL's Human Factors Research & Design team helped the Smith+Nephew myTSF™ Mobile App with user interface design, formative usability testing and HF validation testing.

Enabling safety, compliance and sustainability for health and life sciences innovators

Our safety science expertise and software enable industry innovators to streamline market access, manage cybersecurity risks, build a compliant workforce, enhance supplier risk management and strengthen ESG management capabilities, helping them develop safer and compliant medical products and systems. Download our brochure to learn more.

Advancing the development of safe, compliant medical products and systems.

Our safety science expertise and software enable industry innovators to streamline market access, manage cybersecurity risks, build a compliant workforce, enhance supplier risk management and strengthen ESG management capabilities, helping them develop safer and compliant medical products and systems. Download our brochure to learn more.

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Leverage our market access offerings

Comprehensive offerings for the Health and Life Sciences industry

Cybersecurity

Workforce Training and Competence

Supply Chain Resilience

ESG Stewardship

* Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR, IVDD or IVDR Notified Body, UKCA MD Approved Body or MDSAP Customers.