Fundamentals of medical device software testing

medical device

The last time you purchased a Fitness tracker, a Glucometer, or any other medical device online, did you go ahead and check its reviews? The healthcare industry is currently plagued with hundreds if not thousands of counterfeit medical devices that aren’t compliant with industry regulations.   

Not only are they made poorly, but they also have various software defects that give wrong reading/monitoring of crucial health metrics, thus toying with people’s health. For an industry that deals with human lives, this is entirely unacceptable.   

Therefore, medical device testing of these devices is of paramount importance. With the right quality assurance measures in place, medical device manufacturers and software developers can produce high-quality, reliable products free from defects, ultimately aiding physicians and healthcare professionals in correct diagnoses and treatment.   

In today’s article, we shall discuss the necessity of testing for the medical devices industry and the role QA (quality assurance) plays in healthcare application testing. We will also talk about the challenges that can make medical device testing difficult and discuss possible workarounds.   

Let’s get started:   

Why is QA crucial for the medical devices industry?  

To understand the importance of QA for medical device software, we must first identify its scope. Smart connected health devices now encompass sensor-driven tech, wireless devices, remote patient monitoring and integrated telehealth devices.   

Remote patient monitoring technology has great use for medical devices as it deals with streaming and exchanging real-time health data between physicians and patients. Some benefits of medical device software verification validation and compliance testing include:   

  • Ensuring a seamless integration between all types of medical device software, patient apps, databases and CRMS.   
  • Establishing reliable and sturdy network connections to ensure continual transmission of health data.  
  • Providing an authorized, safe and secure environment to conduct healthcare consultations and health data transmission  
  • Helping medical software developers with compliance testing in accordance with regulatory frameworks.  
  • Eliminating any weak links between interconnected apps that may lead to data leaks.   
  • Always preventing software failure.   
  • Ensuring steady, dependable performance always.   
  • Analyzing health data insights to better support patient needs and being ready to alert physicians and caretakers when metrics show a change.  

Healthcare apps are now flooding the app stores and so are the brands of medical devices in the markets. Gone are the days when there were few key players in this arena. The commercialization of medical devices has led to an influx of small and medium enterprises coming forward with innovative telehealth solutions. Thus, pressing the need for better QA in this sector.   

Medical device testing challenges  

Software testing of medical devices can be tricky in the absence of quality healthcare and medical device testing provider. More complex software means more issues and thus needs more care and introspect into how these challenges can be solved. Here are some of the common hurdles faced by medical device software developers:   

  1. Classification of medical device software based on risks  

Medical device software is categorized according to the FDA’s risk-based device classification system for medical devices.   

Class 1 poses low to moderate risk and is defined as non-life sustaining. Software under class 1 is the least complicated and its failure does not pose much risk.   

Class 2 poses moderate to high risk and is subjected to specific performance standards. It is more complicated when compared to class 1  

Class 3 poses a high risk; therefore, it is subjected to Premarket Approval (PMA). Software under Class 3 is complicated and includes software that sustains or supports life. Hence, its failure is life-threatening.  

It is thus essential for medical device software developers to evaluate and record their classification based on logic. A seasoned QA company with expertise in healthcare testing can help in this regard.   

  1. Building cybersecurity  

Security of patient health information must be taken seriously. With the rising and an alarming number of cybersecurity attacks on healthcare devices in the past decade, it has become even more important to build impregnable levels of safety and security into these medical devices.   

The complexity and sophistication of medical device software make building the proper cybersecurity framework challenging. One workaround can be executing cybersecurity testing at the beginning of the SDLC by identifying the necessary security requirements. It is good practice for medical device software developers to build a resilient cyber security testing framework that includes cyber security test automation, code inspection and manual execution of cyber security test cases.  

  1. HIPAA FDA EMA and IEC compliances  

Medical bodies and regulatory authorities constantly update the criteria determining a medical device software’s usability and safety for patients and doctors. It is hard to stay on top of these compliances without the aid of a QA provider. Thus, a healthcare testing company can ensure regulatory compliance with FDA, HIPAA, DICOM and HL-7 standards necessary for trustworthy medical devices.   

  1. Identifying interoperability issues  

Interoperability refers to 2 or more medical devices exchanging information within themselves in a safe, secure and efficient manner. The most common interoperability concerns with medical devices include   

  • Lost or missing information  
  • Incomplete data integration  
  • No prioritization  
  • Absence of standardized processes  
  • Inability to measure metrics  

Such interoperability challenges can be solved using testing, thus effectively synchronizing interfaced and interdependent components of medical software. 

Read also: essentials hoodie.   


Healthcare is a sector that never stops growing. Over the past three decades, the innovations in the medical devices space have been tremendously helpful in combating age-old diseases, monitoring health and keeping a general check on things.   

With medical devices, it is the marriage of the right software and hardware elements to make a life-saving instrument. Medical device failure or non-compliance with medical body regulations can result in an expensive recall of said instruments causing the loss of hundreds of thousands of dollars. Thus, there is no question of evading a stringent quality check and the verification and validation of the medical device software.   

Working with an experienced and trusted healthcare application testing organization can make a significant difference to your efforts and help you combat any issues with your QA.   

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