Why Quality Assurance & Quality Control are an Essential Part of Medical Device Testing?

Why Quality Assurance & Quality Control are an Essential Part of Medical Device Testing?

Ensuring adequate quality along with delivering products with speed has become the need of the hour noting the current demand for medical devices to support the millions of patients wrapped in the COVID war. At such unprecedented times, we need our MedTech manufacturers to be flexible and robust to the increasing demands for medical equipment like ventilators, oximeters, etc.

With such a pace, the latest study by Meticulous Research on the medical devices testing market states that it’s expected to reach $12.5 billion by 2027, at a CAGR of 4.7% during the forecast period of 2020 to 2027. This growth is predominantly driven by the increasing demand for quick validation and verification of these devices along with ensuring stringent government regulations across the MedTech industry. Moreover, the availability of integration features of these medical devices with mobile applications offers prominent opportunities for equivalent market growth.

In this article, we will try and have a closer insight on the need for Quality assurance and Quality control as an integral part of the medical devices testing services.


Quality assurance and Quality checks of Medical Devices


What is Medical Device Testing?

For those unaware, medical device testing is a basic process of demonstrating that the device will reliable and safe to use at the time of a medical emergency. This is one of the most crucial steps towards transforming an innovative design into a reliable and marketable product in future.

These devices or the entire MedTech industry is governed by multiple regulatory bodies and have to satisfy a set of compliances and standardizations before moving forward. This is where expert medical device testing service providers come into the picture. These giant software testing companies create effective device testing strategies and ensure that your devices are well integrated with your mobile applications, are thoroughly tested and fully functional before their release. Moreover, they need to deliver effective performance, accurate readings and should be safe while in use.

Medical device testing ensures that devices fulfil all quality-related aspects of the product for which you require stringent Quality Assurance and Quality control support that helps deliver optimum quality and reliability of these devices.

Let’s take a closer look at the key difference between Quality Assurance and Quality Control to have a better understanding of these terms and their special role in the medical devices testing industry.


Quality Assurance (QA)

The most essential part of quality assurance is ensuring the right process. Skipping through processes or not following a comprehensive testing strategy that leaves out loopholes can land you to releasing unfinished products that are full of bugs. It’s the job of a QA expert team to maintain these processes to ensure high-quality products are delivered.


Talking about medical devices, comprehensive quality assurance helps prevent flaws in the way a medical device is manufactured by closely observing the entire process.

Quality assurance isn’t a single step, a particular method, or a tactic that can be used at once. It involves a combination of methods and processes to prevent flaws in a device or a system

The Essential Role of Quality Assurance in Medical Device Testing

Your quality assurance services provider closely monitors the medical device development process to ensure that it meets the standards set by regulatory bodies (that include FDA, ISO, etc.), along with the internal quality standards by the company.

A general rule of thumb followed here is the Deming cycle or the PDCA cycle that comes from a four-step process: Plan, Do, Check, and Act:

  • PLAN: plan ahead for a change. Analyze and predict the results
  • DO: execute the plan, taking small steps in controlled circumstances
  • CHECK: study the results
  • ACT: take actions to ensure standardization and help improve the process

The quality assurance testing highlights why we refer to quality assurance as process-oriented.



Unlike QA, the most essential part of quality control is the product. Therefore, quality control experts swoop in once the product is past the development and quality assurance stages. It helps ensure the ‘final product’ is bug-free and abiding by all the necessary quality checks.

Talking about Quality control in medical devices, your QC expert team is predominantly responsible for identifying flaws in a medical device after they have been manufactured but before its market distribution.

Note: looking at the current Covid 19 outbreak, the quality control department has taken a big leap. Device manufacturers need to move quickly enough to help confront those affected by the pandemic while ensuring they safely move past all the criteria mentioned in the quality control department.

The Essential Role of Quality Control in Medical Device Testing

As mentioned above, the role of a Quality control expert is to ensure a fully tested and functional product is launched into the market.

They have a variety of tools at their disposal that are used to test or inspect the manufactured product. They come in once the product is entirely ready for shipment and give a final check to the product before its release.

There are three primary QC tactics followed worldwide:

  1. Acceptance criteria: the quality control staff is responsible to establish a clear acceptance criterion that details the essential quality checkpoints their team will be utilising to determine if the product conforms to the established specifications. They also document, from a batch of products they test, the products that match the set criterion and which did not
  2. Product testing: as per FDA quality system regulations, Medical device manufacturers can enjoy the freedom to design their quality control test but need to ensure that all these tests are well documented and prove the efficacy of the verification process
  3. Corrective and preventive action management: CAPA comes into the picture when a sample out of the product batch tested fails to pass the set quality control requirements. They perform a root-cause analysis to identify and discover a systemic flaw that majorly led to the nonconformance


To state a single line difference: Quality assurance is more proactive and process focussed. Quality control on the other hand is more reactive and product focussed.

It’s the right combination between these two that gives any medical devices testing company the edge to deliver quality products into the market


Enable Quality Outcomes With The Best QA Solutions

If you are a medical device manufacturer then making sure you abide by the quality assurance and quality check regulations diligently is the most vital decision. Noting the fact that you have a life at stake in case your developed product fails to deliver the quality it’s expected, it’s extremely important to either have a full-fledged in-house quality assurance and quality check team or to opt for QA outsourcing to avoid any major fatalities.

Listed below are a few befits that you may receive in case you opt for hiring a QA consultant for a medical device testing service.

  • Reduced project budget
  • Faster time-to-market
  • Continuous support & maintenance
  • Efficient domain expertise

We at ImpactQA emphasizes project and business requirements to provide outsourced software testing solutions that ultimately increases the cost-effectiveness of your QA processes. As a software testing and outsourcing company, we implement the most suitable testing strategy as per your medical device to eliminate various challenges linked to QA processes and out-of-sight costs.


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