Clinical Research Organization Advisory Service

Overview

 

Launching medical devices to the market is an increasingly complex process. As part of a long development life cycle, manufacturers must comply with numerous legal and normative regulations that are constantly evolving in different countries at different times.

As an experienced partner, UL MDT can help companies and manufacturers efficiently identify and comply with necessary regulations for improved speed-to-market and a maintained competitive edge.

Definition

UL MDT provides clinical investigation services in compliance with national and international standards and regulatory requirements. This includes comprehensive project management, data management, clinical monitoring, quality assurance auditing, post market clinical follow-up (PMCF) studies, and regulatory affairs assistance.

Benefits

UL MDT brings together extensive industry and technical experience to help medical device companies develop and manufacture innovative medical devices, and document the safety and effectiveness of these products throughout the product life cycle.

With more than 20 years of trusted clinical and non-clinical testing expertise, we provide a range of clinical research organization (CRO) advisory services to streamline the clinical investigation process and adapt it for the provisions of different countries.

Major clinical investigations are often carried out as multi-national, multi-center studies, which sometimes take part on different continents at the same time. Nevertheless, a high level of integration is needed to gather comparable data.

Our dedicated focus on regulatory developments and the comprehensive planning of clinical investigations enables us to offer cohesive services which save time and resources while helping keep our customers at the forefront of change.

Considering future regulatory changes, such as the planned Medical Device Regulation, clinical data gathered from clinical investigations for conformity assessments are of ever increasing importance. Post clinical market follow-up (PMCF) studies are also getting more attention in terms of clinical assessment.

Our quality of service and our ISO/IEC 17025 based quality management system is assessed and acknowledged by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices.

In addition, we are a member of the German Federal Association of Medical Contract Research Organizations (BVMA) and are regularly audited.


DELIVERABLES

Documents: Clinical investigation plan Patient informed consent forms Report: Compilation of final statistical report, final integrated clinical report


PRODUCTS THIS SERVICE APPLIES TO

Medical devices for which a clinical investigation is required or will be performed for marketing purposes. Products most affected are classified as Class IIb or Class III. In-vitro diagnostics for which a performance evaluation is needed for getting FDA approval, CE mark or other certifications.

APPLICABLE STANDARDS

  • ISO 14155 Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice
  • EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects
  • FDA: CFR Title 21: Food & Drugs
  • ICH Guidelines on Good Clinical Practice
  • Canada: Food and Drugs Act: Medical Devices Regulations (SOR/98-282), Part 3

RELATED SERVICES