MEET MISSION CRITICAL MILESTONES FOR GLOBAL MARKET APPROVALS
UL’s intellectual assets include our team of professionals with vast technical, regulatory and industry experience. We provide an objective and expert perspective on your situation, applying a wide range of resources and experiences to build an integrated approach to solving specific or complex issues related to maintaining compliance to the changing global regulatory scheme.
Our team provides the support needed to help you and your organization understand each country’s unique requirements and receive global regulatory approvals for your medical and IVD devices. This support includes aspects of clinical, non-clinical, technical file submission, quality system inspections, radiation registration, FDA remediation, risk management and the steps involved to submit registrations
Our team can take your product type and specifications and research the current regulatory requirements for the regions of your choice.
Registration support services can start at the point of Classification to walking your technical files submission and hand delivering it to the regulatory authorities and monitoring its progress. We can also answer any questions in real time, in the local language.
We will share our knowledge of market requirements and product specific requirements with your team, customized to meet your objectives.
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