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Heart Valve Device Testing

What Is Heart Valve Device Testing?

Heart valve testing involves evaluating the safety and effectiveness of various types of heart valves and their delivery methods. The device testing process ensures that heart valve replacement or repair procedures are successful and pose minimal risks to patients. Different valve types — mitral, tricuspid and more — and delivery methods both surgical and minimally invasive — require unique, specific testing.

Comparatively, defibrillator testing focuses on assessing the functionality of implantable defibrillators — devices that monitor and correct abnormal heart rhythms. While heart valve testing primarily examines the performance of heart valves and delivery systems, defibrillator testing assesses the electrical components and algorithms of defibrillators to ensure they can effectively treat life-threatening arrhythmias.

Both types of testing are essential to guarantee patient safety and the reliability of cardiac interventions, whether it’s replacing a heart valve to restore proper blood flow or implanting a defibrillator to prevent sudden cardiac arrest. Other cardiovascular biological safety tests that can be conducted to support cardiology or peripheral vascular devices include Transcatheter Mitral Valve Repair (TMVR), cardiac valve repair and testing for beating heart surgery systems.

Compliance with rigorous testing standards is vital to obtain regulatory approvals and ensure these medical devices perform optimally in clinical practice.

Our Heart Valve Device Testing Process

The amount of trials and testing a new heart valve product has to go through before commercialization can vary significantly depending on several factors, including the type of heart valve, its complexity, the regulatory requirements in the intended market and manufacturer-specific goals.

Generally, the process includes several stages:

  • Preclinical laboratory research and testing to evaluate the safety and efficacy of the new heart valve 
  • Clinical trials where the heart valve is tested in human patients across a variety of phases 
  • The collection and review of data by regulatory agencies from both preclinical testing and clinical trials — ultimately leading to approval for commercialization

Heart valve development is a complex and highly regulated process — thorough testing and evaluation are crucial before commercialization. A partner like NAMSA can expedite the process safely, efficiently and effectively.


Accelerate Commercialization

Discover the NAMSA APEX Program™, a groundbreaking solution for successful medtech commercialization. With a team of top subject matter experts in the MedTech industry and a proven set of integrated services and tools, it paves the way for predictable planning, phase overlap, and vertical integration across all development stages to save you on time and costs on the way to accelerated commercialization.

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Accelerate your heart valve’s path to regulatory approval and commercialization by scheduling a consultation today.