Our expertise and software help customers streamline regulatory affairs and compliance. Our testing capabilities help demonstrate medical product safety and performance.
UL Solutions offers product development and regulatory expertise as well as software to support innovation and streamline compliance in health and life sciences. Our testing and certification services help customers demonstrate compliance to safety and performance requirements necessary to achieve market access.
Addressing evolving global health regulations without in-house expertise.
Deploying human factors resources and skills needed for safer, user-friendly product design.
Compliance complexity across fast-growing digital health solutions.
Third-party testing and certification services to help companies demonstrate compliance with product safety and performance standards and regulatory requirements.
Regulatory experts provide consulting and software to help automate regulatory affairs, streamline market submissions and keep up with regulatory changes.
Consulting and software support to help product developers and R&D professionals address regulatory compliance and usability requirements.
Accelerate market access with centralized compliance tracking, real-time regulatory updates and enhanced portfolio visibility.
We help customers achieve their safety, compliance and sustainability goals with our regulatory expertise and software.
Leverage our market access experience and let our team of experts help support your market access strategy.
To achieve market access, manufacturers of pharmaceuticals, medical devices and other medical products must demonstrate compliance with regulations, as well as quality, safety and performance standards and related requirements in their target markets. Companies must also keep up with changes to regulations and standards in order to maintain market access once they successfully register their products.
Medical product manufacturers may want to consider which of the largest medical markets — the U.S., Europe, Japan — to target first, as well as how market access in these jurisdictions could mean expedited market pathways in other countries. Manufacturers should also consider factors such as the depth and breadth of their in-house expertise and capacity to automate regulatory affairs processes.
Regulatory affairs entail supporting ongoing compliance of medical products to all relevant regulations in markets where those products are registered for sale. For manufacturers of medical devices, in vitro diagnostic devices (IVDs), pharmaceuticals and biologics, regulatory affairs include market access submissions to regulators, product life cycle management and post-market surveillance to maintain market access.
* 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.
