Clinical Services Audit

Overview

Rely on UL's Clinical Services to assess the safety, usability and effectiveness of higher-risk and new medical and in vitro diagnostic devices such as orthopedic, ophthalmic and many cardiovascular implantable devices. With a complete portfolio of services to support access to the major medical markets, we help the medical industry navigate the complex regulatory requirements needed to bring their products to market around the world.

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

From sterile gauze and bandages to more complex devices such as bone screws; contact lenses; and orthopedic, dental and other implantable devices, UL's experience in clinical evaluations will help manufacturers develop products that will keep patients healthy. We also offer technical documentation services that enable medical device manufacturers to demonstrate product safety to regulatory authorities around the globe.

Benefits

UL is accredited as a Clinical Research Organization (CRO) for medical devices under the EU Medical Device Directive (MDD) and Active Implantable Medical Devices (AIMD) directive and ISO 17025 for collection of clinical data.

MDT, a UL company, is accredited as a CRO for medical devices under the MDD and AIMD and ISO 17025 for collection of clinical data in humans.

UL clinical services are flexible and comprehensive, so we can complete all aspects of the sponsor's clinical investigations or take on one selected area where you may need more support.

UL's family of companies can provide clinical services for both pre-market and post-market clinical investigations. This includes European MEDDEV 2.12/2 studies and FDA-mandated PAS and CFR 522 studies.

By working with UL for your clinical, nonclinical, safety, EMC and management systems registration, you can save time by working with one vendor who understands your device and business.


DELIVERABLES

Clinical trials project management, preparation of investigator’s brochure, study site selection and initiation, writing of protocol (clinical investigation plan), on-site monitoring, patient consent forms and other medical writing, statistical analysis of results, final integrated clinical study report


PRODUCTS THIS SERVICE APPLIES TO

Active, inactive and implantable medical devices, IVD devices

APPLICABLE STANDARDS

ISO 14155-1 Investigations into medical instruments for human use »
ISO 14155-2 Investigations into medical instruments for human use »
Medical Devices Directive 93/42/EEC21 - Europe Requirements needed to have a medical device in the European market » 
CFR - FDA Good Clinical Practice FDA Good Clinical Practice. 

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