Importance of Quality Assurance and Quality Control in Medical Device Testing and Calibration

Importance of Quality Assurance and Quality Control in Medical Device Testing and Calibration

Medical equipment quality control and quality assurance (or QA) program are essential to keep medical devices safe, reliable and effective for use. This includes inspection, preventive maintenance, safety evaluation, and performance testing. The responsible authority for establishing and managing medical equipment QA programs and technicians performing inspections and device testing have sound knowledge about the entire procedure. Medical equipment QA is part of a complete medical equipment management program for a healthcare facility or system. A comprehensive program also includes health care technology planning, asset management or equipment control, preventive and corrective maintenance or repair, education, and activities to improve medical device-related patient safety. Read details about why does every hospital need a medical equipment maintenance programme.

Objectives of the medical equipment maintenance program

Any medical equipment maintenance program's purpose is to guarantee that medical equipment is safe, accurate, and ready to use by patients. The equipment is checked regularly to ensure quality. The goal of risk-based maintenance intervals is to deliver high-quality, cost-effective inspections based on risk and function, historical data on problems detected, and the impact of maintenance on reducing issues.

PM/Inspection methods should be based on necessity, including the equipment's maintenance requirements, risk classification, device function, and incident history. Random failures, particularly in electronic equipment, are not prevented by routine maintenance and performance assessments. Low-risk devices do not require the same level of performance verification as higher-risk devices.

The frequency of testing should be determined by evaluating medical equipment. If a device isn't tested frequently enough, it could fail before it's due for maintenance or produces incorrect findings. The job of the biomedical professional is to maintain a balance between the time and effort required for routine functional testing and the safe operation of medical equipment.

Risk-based inspection intervals

The frequency of inspection must be chosen to maintain an efficient maintenance programme. Equipment where testing is anticipated to have an impact on the medical device's continued safe operation, should be prioritized. Equipment inspection intervals are set depending on risk, requirements, logistics, and history. According to the Maintenance Strategy Worksheet, written criteria are utilized to identify risks associated with medical equipment. Equipment function, physical dangers linked with use, and equipment history relevant to patient safety are among the hazards. The life support equipment is particularly identified and given top priority in terms of action.

Risk criterion is divided into five categories

Clinical function, physical risk, the likelihood of avoiding a problem, incident history, and regulatory or manufacturer requirements are all factors to consider.

For each of these criteria, devices are given a score. Each instrument type's overall score is calculated by adding the scores from each category. The scores for each group
are added up, and an overall score is given for each device category. As a result, a more cost-effective testing programme will be developed, which will improve patient care by reducing equipment downtime.

The importance of a quality management system for medical devices

A quality management system (QMS) for medical devices is essential for ensuring that manufacture and performance satisfy the design specifications. Quality assurance and quality control are two crucial components of a good QMS.

a quality management systemSome of the main steps of a quality management system. An excellent QMS is comprehensive and covers all bases.

  • Design
  • Supplier management
  • Complaint handling
  • Documentation
  • Product labelling and
  • Risk management

What is medical device testing, and why is it important?

Medical device testing is important in ensuring that a device is reliable and safe to use in an emergency. This is one of the most momentous steps in making an innovative design a commercial and reliable product in the future. Medical device testing guarantees that all components of the development process are met in terms of quality. Hospital biomedical engineers' responsibility is to ensure that a medical device is tested and calibrated regularly. Watch the webinar on Medical Device Quality Assurance Testing: Best Practices for Patient Risk Reduction.

PDCA cycle

The PDCA cycle is a simple approach to comprehend how the quality assurance system works at various levels in a manufacturing facility. PDCA cycle includes Plan, Do, Check, and Act (PDCA).

PDCA cyclePlan

This stage aims to evaluate existing methods using established industry standards or a more advanced reference. This step requires predictive analysis to propose improvements that would improve the process while maintaining traceability.


The second stage is the implementation phase, which involves putting all the improvements identified during the initial evaluation phase into action.


The check step entails a thorough assessment of the changes and their testing. If the procedure' observable effects are favourable, the improvements achieved will be long-lasting.


This stage entails putting the suggested facility upgrades into practice, following all checks and evaluations. Finally, adjustments can be implemented to reduce costs, increase efficiency and confidence.

Most common quality control strategies used around the world:

Acceptance criteria:

The quality control team oversees creating a clear acceptance criterion that outlines the critical quality checkpoints that their team will use to decide if the product meets the stated requirements. They also record which products met the given criterion and did not form a batch of tested products.

Product testing:

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

Corrective and preventive action management:

When a product fails to meet the quality control standards, approval is invoked. They conducted a root-cause analysis to uncover and locate a systemic defect that contributed significantly to the nonconformance.

Medical device approval and Quality Management System (QMS)

The quality management system receives FDA approval for the product(s) or CE marking in the European Union. The United States Food and Drug Administration (FDA) mandates that the specific medical devices comply with 21 CFR Part 820 when registered with the agency. The 510(k) method will be used by the majority of companies that make medium-risk devices. Surprisingly, even though QSR compliance is necessary, FDA does not require proof of conformity when registering a Class I or Class II device. Random inspections are used by the US FDA to ensure compliance. As a result, FDA inspectors may show up at the door of a newly registered medical device's maker at any time.

With the Best QA Solutions, healthcare management can ensure that quality outcomes are achieved. At Iconic Engineering and Pico Labs Limited, we emphasize regulatory standards to deliver testing and calibration solutions that expand the efficiency and cost-effectiveness of quality assurance procedures. To reduce numerous issues associated with QA processes, we implement the best testing method for each device to ensure overall medical equipment quality control and quality assurance.