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Risk Analysis of Medical Devices

A medical device is used on patients for providing medical treatment, but unlike drugs, they mainly have an effect on the physical part of the body – for example, a thermometer – it assists in identifying the temperature of the body.

However, medical devices are prone to failures and may have a significant impact on the patient’s life. So, it is necessary that a medical device undergoes stringent quality checks. With the medical industry evolving everyday, new quality benchmarks and better medical equipments is the need of the hour. Furthermore, conducting a risk analysis ensures that the risks associated with these products are eliminated or minimized.


Risk Analysis is the process of identifying the perils associated with a product and eliminating or minimizing these perils. A risk analysis is conducted to ensure high-quality, reliability and safety in products during manufacturing.

Need for Risk Analysis

With laws being stringent by the day, it has become mandatory by law that every product meets certain norms and hence, must undergo a stringent risk analysis program. This ensures that there is a regulatory system for checking the quality of products, especially medical devices.

Some of the primary objectives of Risk Analysis include:

  • Quality
  • Safety
  • Performance of equipment during its life time
  • Properties of the equipment
  • Effects of Radiation
  • Sterilization
  • Risk control measures

Medical devices must have a high level of safety and protection along with excellent performance. The safety principles must be incorporated in the design while the performance must be reliable throughout the life expectancy of the equipment.

Evolution Of Risk Analysis Into GMP Of Medical Devices

The radical reason for the inclusion of risk analysis in GMP is the occurrences of injuries to patients receiving treatments, especially for treatments like electric-shocks, over-fusion and over dose of radiation. Some of these treatments have even led to the death of patients – an example is the computer controlled radiation therapy called the Therac 25, which overdosed six people with extremely fatal results.

Tools used for Quality Assurance of Medical Devices

There are mainly three tools that have been identified for pre-production quality assurance – Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA) and Failure Mode Effects Critically Analysis (FMECA).

FMEA assumes that there is a defect at the component level. Then, looks at the effects and finally, identifies the solution – this tool is mostly used at the design phase. The FMECA adds probability of occurrence and severity of failure to the FMEA process. On the other hand, the FTA identifies a failure or hazard and then, efforts are made to create that failure or hazard.

Risk Analysis has become a very vital part of the manufacturing process and hence, is part of the GMP. With new medical devices emerging into the market everyday, no product can be used without conducting a risk analysis. All products must provide quality assurances with proper guidance of usage and should be free from any kind of hazards.

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