Clinical Evaluations

Overview

The requirements for clinical evaluation of medical technologies have increased dramatically in the last few years around all regulatory systems worldwide. We provide clinical evaluations to ISO 14155 Part 1 as part of clinical investigation applications, literature reviews and post-market reviews and, when required, can ensure technical documentation is up to date.

We also perform clinical literature reviews for ISO 14971.

For more information about clinical evaluation services in the U.S., email medicaldevices@nsf.org or call +1 202.822.1850.

For more information about clinical evaluation services in Europe, email eudevices@nsf.org or call +44 1143 600 868.

 
Services

ISO 14971 - Risk Management Clinical Literature Review

Before a product risk analysis can be undertaken, ISO 14971 advocates the use of a preliminary hazard analysis. We provide a critical evaluation of all published scientific and clinical literature of devices and technologies in order for you to understand harms, hazards and risk acceptability for a particular device.

Clinical Investigation Application

As part of any clinical study application, an assessment of published literature associated with the device or therapy area is required to demonstrate that your study objectives will be beneficial. We undertake clinical literature reviews and produce the evaluation report for regulatory agency clinical investigation applications.

Clinical Evaluation - Submission Phase, ISO 14155 Part 1

We have extensive capabilities in clinical evaluation of medical technologies enabling you to understand if clinical investigation is necessary. Our service includes establishing the generation, identification and review of clinical literature in order to establish the safety and effectiveness of a device technology. We are skilled at advising our clients in what the best literature review methods are and we produce high quality evaluation reports that are regulatory agency submission ready.

Post Market Clinical Follow-Up and Post-Market Surveillance

We provide periodic evaluation of clinical data relating to products in market and include competitor product performance and reportable incident. We also review any available internal data from your company quality system.

 
Why Work With NSF?

NSF maintains a commitment to outstanding service and quality. We focus on your business objectives through the use of sound science and proven expertise. Initial consultations are provided as a professional courtesy. Our expertise covers a wide range of therapeutic areas, product types and regulatory specialties.