Regulatory Support Advisory Services

Overview

UL's Regulatory Support Advisory Services provides actionable, expert information and support aimed at easing the complexity of doing business in the global healthcare market.

Manufacturers must identify and comply with a 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.

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, 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 brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.
Definition

The regulatory support advisory services that UL provides to manufacturers include product classification support, technical documentation support, regulatory submission, quality system support, radiation registration, Food and Drug Administration (FDA) mock audits and remediation, risk management, software validation, and regulatory strategy.

Benefits

UL's customer-oriented team approach helps our customers meet their global market launch objectives as well as make smart use of time and resources.

UL's industry experts work on our customers' behalf throughout either the entire or select parts of the submission process, according to the customer's needs and specifications. We also assist our customers in developing continuous compliance plans.

Our global presence typically enables us to provide a local point of contact to help cut through regulatory complexities. Each market is distinct in how it classifies products, what tests are required, the application and approval process, and its ongoing compliance demands. Having an expert local contact who is able to speak with regulators in their preferred language is key to receiving the right information in a timely manner.

For the US market, UL can provide full product life-cycle support of our customers' products from design concept to end of life, including regulatory support, technical documentation, and FDA inspection support.

For companies under US FDA inspection, UL provides both preventative assessments and remediation support by quickly mobilizing the right experts to develop and deploy a plan to move the company toward resolution and compliance. Our team can provide assurance through an independent third-party review of the implementation of corrective actions.


DELIVERABLES

  Can be used to submit device to specified regulatory bodies Assessment or gap analysis findings


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