Medical devices, due to their direct use on or in the human body, must prioritize safety and effectiveness.
As a result, regulatory authorities in each country have established stringent verification and validation processes.
Joseph Shen, Senior Manager of Medical Affairs, BE Health Ventures
This article focuses on non-implantable, powered medical devices, introducing key concepts and common testing requirements for teams and investors.
The article is divided into two parts — the first introduces the fundamental concepts, while the second explains verification requirements in more detail.
The Core of Medical Devices: Safety and Effectiveness
The essence of every medical device lies in ensuring safety and performance efficacy.
To achieve the claimed functions of a device, potential risks must be reduced to an acceptable level through appropriate design and testing.
Each product must undergo a reliable verification process, supported by quality system documentation and technical files—such as test reports, risk analyses, and clinical evaluation reports—to demonstrate that it can be used safely and effectively by end users.
Definition of a Medical Device — Example from the U.S. FDA
Before discussing verification, it is crucial to understand what defines a medical device.
While definitions vary slightly across jurisdictions, the U.S. Food and Drug Administration (FDA) defines a medical device as:
“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals, or intended to affect the structure or any function of the body of humans or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of its primary intended purposes.”
The FDA categorizes medical devices into three risk-based classes (Class I, II, III), where the level of regulatory control corresponds to the risk to the patient.
Most non-invasive, powered medical electrical devices fall into Class II, which typically requires a Premarket Notification [510(k)] prior to marketing.
Medical Device Market Authorization
When applying for market clearance, manufacturers must define the device’s Intended Use and Indications for Use.
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Intended Use refers to the overall purpose or function of the device.
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Indications for Use describe the specific diseases, conditions, or patient populations the device is designed to diagnose, treat, prevent, or alleviate.
While closely related, Indications for Use are a subset of the broader Intended Use.
Example: Ultrasound Imaging System
For instance, a general diagnostic ultrasound system listed on the FDA’s database is classified as Class II and cleared via the 510(k) process.
Its Intended Use is defined as diagnostic ultrasound imaging and fluid flow analysis in humans.
Its Indications for Use specify that it is a general-purpose ultrasound imaging system used for cardiac imaging by qualified physicians or under their supervision.
It can be applied for various diagnostic purposes, including:
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Fetal/obstetric, abdominal (including renal and gynecologic) imaging,
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Pediatric and small organ (breast, testes, thyroid) imaging,
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Neonatal cranial and adult head imaging,
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Cardiac (adult and pediatric), peripheral vascular, musculoskeletal, and urological imaging (including prostate),
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As well as transesophageal, transrectal, and transvaginal applications.
Next Steps
In the next part, we will explore the key testing and verification requirements for medical electrical equipment, offering an overview that helps both development teams and investors quickly understand the regulatory expectations.
This foundational knowledge supports product planning, risk management, and due diligence evaluation across the medical device lifecycle.
For more information, please contact: Joseph.Shen@be.tworg.app
