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. (Source)
14%
Rise in medical device recalls in 2024, driven by stricter regulations and enforcement. (Source)
1.77 billion
People are expected to start using digital health products by 2029. (Source)
34%
Of medical product recalls are due to poor design controls. (Source)
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
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
As a global safety science leader, UL Solutions offers rigorous and impartial third-party testing and certification services to help companies demonstrate compliance with product safety and performance standards and meet global regulatory requirements.
Regulatory Readiness and Compliance
Our network of regulatory experts helps customers achieve market access in more than 20 countries. We provide consulting and software to automate regulatory affairs, streamline market submissions and keep up with regulatory changes*.
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
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.
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.
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.
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*.
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*.
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*.
Featured resource
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.
Related market access resources
Comprehensive offerings for the Health and Life Sciences industry
Cybersecurity
We offer software, testing and expertise to manage cybersecurity risks and develop safer manufacturing processes under the Industrial Internet of Things (IIoT).
Workforce Training and Competence
We offer learning management software to help companies implement training programs, standardize manufacturing processes and keep pace with regulatory changes.
Supply Chain Resilience
Our software and services provide visibility into firms’ supply chain networks, helping to minimize disruptions and mitigate supplier- and product-related risks.
ESG Stewardship
We offer software and advisory expertise to manage ESG reporting, reduce carbon emissions and more sustainably bring medical products to market.
* Within UL Solutions, we provide a broad portfolio of offerings to many industries. This includes certification, testing, inspection, assessment, verification and consulting 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’ brands, UL Solutions has processes in place to identify and manage any potential conflicts of interest and maintain the impartiality of our conformity assessment services.
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