Managing the integration of safety and risk management is a vital key to successful medical device development. Many of the requirements of the safety standards are verified by inspection of your risk management file.

This article will introduce you to elements of proactive safety by design approach at a general level.

Make a plan for proactive safety by design

All manufacturers of medical devices aim to ensure that their products are safe and effective. It is also a regulatory requirement for any market where you would sell your product.

Considering the diversity of medical devices, how they are used and the technologies they employ – this can be challenging. Therefore, standards have been developed to help manufacturers, test houses and regulators.

By knowing how the safety standards for electrical medical devices are structured, you can navigate the standards and identify the relevant requirements with greater ease.

All these standards in combination define what is called basic safety and essential performance for different types of medical devices.

Medical device development overview chart

This plan should identify who is going to do what and when they are going to do it. It should also tell you how much activity is relevant, justified or practicable to assign to proactive safety by design.

How to meet the general requirements

Below are the four general requirements to address in the risk management file. These must all be met effectively, by ensuring that they are addressed in your final risk management file for your medical device.

Requirements to address in risk management file overview

The aim of safety engineering is to design a safe product while ensuring compliance with the standards. Adding hundreds of lines to your risk analysis matrix is not the way to achieve this; it would rarely meet the objectives and is likely to cause a lot of confusion.

Let’s focus on the column to the left labelled ‘Complete?’ in the table above. In order to identify if the requirements of the standards address all hazards associated with your device, you must consider two questions:

  • Which hazards are associated with your device?
  • Which of the requirements of the standards apply?

When you have done your analysis and answered these questions, you can perform a gap analysis, to identify any relevant hazards that are not fully covered by the standards.

Once the gap analysis is complete, you can go on to defining these additional requirements. This includes evaluation methods and acceptance criteria, allowing you to conclude that the risk is reduced to an acceptable level.

Combining the results of these analyses will give you a full list of the safety-related requirements applicable to your device. Some requirements will be defined by the standard, while others may be defined and justified by you.

The image below demonstrates this process, step by step.

Identify requirements chart

You have now reached an important checkpoint and an appropriate stage in which to do a design review to ensure that you have carried out planned activities and that the results of the activities are relevant, correct, complete and consistent.

It is also a good idea to ensure that both activities and documentation are included in the risk management file and integrated into your risk analysis. If not, you may want to revise the plan or repeat relevant activities.

All of the recognised characteristics related to safety and hazards identified during the activities should be included in your risk analysis. Identify a hazard for each identified relevant requirement, whether it is identified by you or the standard.

In your risk analysis matrix, you then continue to complete risk analysis by defining foreseeable sequences of events and their resulting hazardous situations followed by risk estimation. The gap analysis should also be documented and included in your risk management file.

The safety requirements identified as relevant to your medical device should be fed into the risk control process. This is a process by which you identify risk control measures that are appropriate for reducing the risks to an acceptable level. Typically, this translates into a means of protection in IEC 60601.

Free Download IEC-60601-1-3.1 Checklist Template download description

Would you like to know more about safety for electrical devices?

If you want to know more about the 60601 standard and safety for electrical devices, take a look at our online course Introduction to Safety for Medical Devices and IEC 60601. This comprehensive course has in-depth information and quizzes to test your knowledge and understanding. At the end of the course you will also receive a course certificate, which many auditors will be looking for.

Our online courses are frequently taken by competent authorities, notified bodies and medical device manufacturers and distributors.

Claus Rømer - Instructor

Claus Rømer Andersen

Claus Rømer Andersen is an accomplished trainer, consultant and facilitator in the medical device industry. With a background in electrical engineering, he has worked with regulatory navigation, approval management, device testing throughout his whole career.

He is recognized as having a pragmatic and solution oriented approach to helping development teams focus on relevant issues throughout the entire product life-cycle.