We have the expertise to set up and manage clinical trials designed to demonstrate clinical safety and performance of a medical device for CE marking according to ISO 14155, as well as obtaining post-market surveillance clinical data on commercialized 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 carried out in human subjects 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 ISO 14155 standard to demonstrate compliance with EU requirements for clinical investigations. Similarly, In Vitro Diagnostics (IVD) medical device manufacturers shall comply with ISO20916 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
- 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 and as such we provide clients extensive experience and seasoned leadership in the conduct and management of human 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
Post-Market Clinical Follow-up (PMCF) Studies in Europe
Post-market Clinical Follow-up (PMCF) is an important part of ongoing medical device regulatory compliance in the EU.
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
Clinical Performance Studies for IVDs
AKRN provides the state of the art timelines to set-up and conduct clinical performance studies in compliance with ISO20916:2019
We have the expertise to compile the analytical performance data and complement it with the required clinical performance data necessary for CE Marking.
We are building an extensive and fast-growing network of biobanks, laboratories, clinics and hospitals to ensure timely availability of specimens while maintaining our high standards for study conduct.
We specialize in providing CRO solutions that balance quality, timelines, and budget, using scientifically rigorous methods.
Clinical Performance Study Planning
- Study, design, planning & optimization
- Site nomination
- Clinical Performance Study Plan (CPSP)
- Investigators Brochure (IB)
- Case Report Forms (CRFs)
- Informed Consent Form (ICF)
- Preparation of Study Plans: Monitoring, Data Management, Statistical, Safety, etc.
- Ethics Committee (EC) and Competent Authority (CA) Submission
Clinical Performance Study Conduct
- Site Selection/Qualification Visits (SQV)
- Site Initiation Visits (SIV)
- Interim Monitoring Visits (IMV)
- Source Data Verification (SDV)
- Close-Out Visits (COV)
- Study Documentation Control
- Adverse Event (SE) Reporting
- Interim and final database lock
- Data analysis and reporting
Recent AKRN Projects
Heart Valve Disease – Aortic and Mitral Valve Disorders
350 patients in a prospective multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
1000 patients in a prospective multi-center, real-world setting. This study is designed to confirm the safety and performance of the device.
150 patients in a prospective multi-center, clinical trial to evaluate the acute safety and effectiveness to support CE Mark and FDA approval.
Aortic Diseases – Abdominal Aortic Aneurysm
30 patients in a FIM prospective multi-center, non-randomized, single arm clinical trial to evaluate the safety and performance to support CE Mark.
60 patients in an FIM prospective multi-center, non-randomized, single-arm clinical trial to evaluate the safety and performance to support CE Mark.
500 patients in a prospective multi-center, post-market registry in the real-world setting
1000 patients in a prospective multi-center, post-market registry in the real-world setting
60 patients in a prospective multi-center, non-randomized, single-arm clinical trial to evaluate the safety and effectiveness to support CE Mark for percutaneous cardiac ablation to treat paroxysmal atrial fibrillation.
Coronary Artery Disease
260-patients prospective multi-center, randomized, clinical trial to support clinical follow-up requirements of CE Mark in Europe.
15,000 patients in a prospective multi-center, global registry in a real-world setting.
2,400 patients in a prospective randomized multi-center registry in a real-world setting in Sweden.
Bacteremia and Sepsis Management
15 patients in a prospective multi-center FIM clinical trial to evaluate the safety and performance to support CE Mark.
Spinal Cord Injuries
70 patients in a phase II FIM clinical trial to evaluate the safety and efficacy of Neuro-Cells treatment.
300 patients in a prospective multi-center, randomized, double-blinded pivotal clinical trial to evaluate the safety and effectiveness of Class III device.