Risk occurs in all our lives, it’s a part of our everyday living. To minimise the threats from risk and maximise their potential we need to manage our risks; this equally applies to the field of medical device development.  By implementing a risk management process, you are simply applying a management tool to help medical device developers assess their product design with regard to exposing customers (patients, carers, healthcare professionals) to hazards; hazards which can cause loss of or damage to health or to something they value.

In evaluating risk there are two components:

  1. The probability of occurrence of harm.
  2. The consequences or severity of that harm.

What complicates Risk Management is that it places different values on the probability of harm occurring and its severity. Three Circles can help you with this complexity by:

  • Providing you with an understanding of what is expected from medical device regulators for Risk Management.
  • Using Risk Management as a tool to design safer medical devices by providing early indications of potential design issues.
  • Guiding or defining your Risk Management procedures.

Regulatory requirements for Risk Management processes

Risk Management is a primary focus for medical device regulatory agencies. In fact, regulatory authorities, including FDA, use risk-based processes throughout their own internal activities when reviewing device submissions, conducting inspections and audits.  Authorities require you to have a defined Risk Management process and Risk Management documentation for your products.

Most Authorities refer to ISO 14971 “Medical devices — Application of Risk Management to Medical Devices”, which provides an outline for the structure of your Risk Management process.  In addition to ISO 14971, there are other key medical device industry standards requiring risk management:

  • IEC 60601-1-11:2015 – Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
  • IEC 62366-1:2015 – Medical devices — Part 1: Application of usability engineering to medical devices
  • ISO 10993-3:2014 – Biological evaluation of medical devices
  • ISO 13485:2016 – Medical devices — Quality management systems

ISO 13485 is exceptionally relevant, as there is the additional expectation that you manage risk throughout the entire product lifecycle and throughout your entire Quality Management System.

The goal of Risk Management is to identify, evaluate, analyse, assess, and mitigate potential product issues, which relates directly with Design Controls. With Design Controls, you also identify, evaluate, analyse, assess, and mitigate potential product issues.  With our specialist knowledge in both these fields we are ideally suited to help you.

Risk Management benefits to our clients

We can either supply resources to help implement your Risk Management systems and procedures or we can research and write it all for you, train your staff and hand it over to your internal resources to maintain.  We can also provide expertise to take care of project Risk Management for you.

The typical benefits our clients gain are;

  • Risk Mitigations tested early, reducing design costs
  • Reduction in development process costs
  • Documented traceability of risk control to product features and testing
  • Shortening the time to finish development