STAY AHEAD OF REGULATORY CHANGES
UL’s Regulatory Support Advisory Services guides the medical and IVD manufacturers with actionable, expert information and support aimed at easing the complexity of doing business in the global healthcare market.
Medical device and IVD manufacturers must identify and comply with myriad of regulatory requirements in all the markets in which they do business. UL helps our customers understand and comply with the regulations they must meet to receive global approvals. We also provide support in achieving continuous compliance with regulatory quality system requirements through both preventative and remediation assessments.
The regulatory support advisory services that UL provides to manufacturers of medical and IVD devices include product classification support, technical documentation support, regulatory submission, quality system support, radiation registration, Food and Drug Administration (FDA) mock audits and remediation, human factors engineering, risk management, software validation, cybersecurity and regulatory strategy, including labeling reviews.
Our expert staff around the world can help our customers with regulatory submissions, including researching and providing detail on the regulatory requirements for devices, identifying required tests, preparing technical documentation and managing regulatory submissions. Our labeling reviews can help steer companies clear of regulatory minefields by avoiding unsubstantiated claims.
For connected medical devices, our dedicated eHealth team can help manufacturers understand and meet the regulatory expectations outlined in the FDA’s guidance for integration of RF wireless technology in medical devices and specific requirements for other regulatory markets.
Health information technologies (HIT) infrastructure uses equipment that has been traditionally designed for general purpose IT. When employed in a HIT network, the equipment can then be part of a medical device data system (MDDS) and is subject to regulatory classification and oversight. UL can help you determine MDDS classification and how to apply the Final Rule to reduce regulatory burden for market access.
Usability is more than just a regulatory imperative. It can contribute to commercial success and is a critical component of risk reduction. Our human factors engineering (HFE) design experts have been leading contributors to today’s prevailing HFE process and applied-user interface design standards for the development of medical devices, combination devices (devices containing drugs), and laboratory and scientific instruments and can provide expert advice for your regulatory submissions.
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