Clinical Studies for Medical Devices

The ISO 14155 standard is released by the International Organization for Standardization (ISO). This affects all medical device manufacturers and is now the standard of reference for conducting medical device clinical studies in the UE countries, the United States, and Japan.

The ISO 14155 standard was created to clarify the design, conduct, recording, and reporting of clinical investigations to assess the safety or performance of medical devices for regulatory purposes. ISO 14155 is now in its third edition: ISO 14155:2020. 

While ISO 14155 is not a law in the United States, it plays a role similar to ICH Good Clinical Practices Guidelines (E6) and has been officially recognized as a standard by the FDA.

It is important for Medical Device Manufacturers to use the ISO 14155 standard to demonstrate compliance with EU requirements for clinical investigations. Similarly, In Vitro Diagnostics (IVD) medical device manufacturers shall comply with the ISO 20916 standard to meet the EU requirements for clinical performance studies.

FDA regulations and ISO 14155 standards include many overlaps, but also some unique aspects. To comply with both, it is important to understand these differences. 

We specialize in providing creative clinical solutions that balance quality, timelines, and budget using scientifically rigorous methods.

• Clinical Project Management
• Clinical Consulting Services
• Ethics Committee/Competent Authority Submissions
• Essential Clinical Investigation Documentation
• Investigator’s Brochure (IB)
• Clinical Investigational Plan (CIP)
• Informed Consent Form (ICF)
• Case Report Form (CRF)
• Clinical Site Selection and Management
• Monitoring
• Statistical Analysis
• Data Management
• Publication Policy
• Clinical Trial Registration on clinicaltrials.gov

We are experienced professionals who can provide monitoring of your clinical procedures to verify that the device is used as you intended. Our clinical research associates guarantee up-to-date knowledge of your trial status at each participating hospital following Good Clinical Practices (GCPs).

AKRN consulting also collaborates with clinical partners focused on biotechnology and medical device product research. As such, we provide clients with extensive experience and seasoned leadership in conducting and managing clinical trials in most disease areas.

• Site Qualification Visits
• Site Initiation Visits
• Clinical Monitoring Visits
• Source Data Verification (SDV)
• Close-Out Visits
• Trial Document Handling
• Safety Narratives
• AE reporting

Notified Bodies (NBs) most likely will require you to conduct additional clinical investigations, called PMCF studies.

We can describe PMS and PMCF studies in the context of the change from the current Medical Devices Directive 93/42/EU (MDD) to the new Medical Devices Regulation (MDR 2017/745/EU), as well as how current PMCF activities can help your transition to the MDR.

Points to consider:

• How PMCF study requirements change under the MDR
• PMCF study requirements under the MDD
• The difference between a clinical investigation and a PMCF study
• Important considerations when conducting a PMCF study