Risk Management in Medical Devices is a complex process and requires a strategic approach requiring careful analysis of steps involved in the manufacturing process. ISO 14971 requires specific practices meant for strategically implementing risk management in a Medical Device Development Process. The entire process is divided into several segments including:

  1. Analyze
  2. Evaluate
  3. Control
  4. Monitor Risks

What is defined as a risk?

The probability of occurrence of harm and the severe effect it can cause is defined as “Risk”.

Why is Risk Management needed?

Medical devices are unlike any other commodity of use. It is important to have a risk management system that prevents major flaws and ensures safety for the medical device. The US FDA mandates Quality System Regulation (21 CFR Part 820). The regulations ensure that the devices being developed are safe and offer high-quality medical devices.

The Role of ISO 14971

The core intent of implementing ISO 14971 is to identify major risks and implement strategies accordingly. The structure of ISO 14971 is outlined in a way to come up with solutions for effectively eliminating the risks associated with each step of the manufacturing process.

The strict harmonized ISO 14971 outlines specifications for risk management in medical devices:

  1. The risk policy for the device must be clearly outlined
  2. The risk associated with the device must be minimized as much as possible


What is ISO 14971?

ISO 14971 is a set of guidelines that outlines the strategies to implement for minimizing the risks to an acceptable level. 

Is the application of ISO 14971 mandatory for Medical Device units?

The application of ISO 14971 is not mandatory by the ISO 13485:2016 Clause 7.1 [ Note: ‘Further information can be found in ISO 14971’] 

This implies that ISO 14971 is not mandatory for medical devices but the auditors may evaluate the strategies you’ve adopted across the organization for minimizing the risks at different levels. The measures adopted and strategies implemented must be in sync with ISO 14971. 

Does FDA mandate risk analysis during Medical Device Manufacturing?

Yes, FDA guidelines mandate risk analysis throughout the Medical Device Development process.  

Can TENS cause any health risks during or post usage?

No, in general TENS does not cause any major health risk. For highly sensitive skin the device usage for long hours can cause redness or patches on the skin.  

Are there risks associated with Ultrasound therapy devices?

No, there are no risks associated with Ultrasound devices. Therapeutic ultrasound is completely Non-invasive and has minimal damaging effect on the skin.



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