Risk Management is a vital component to developing and designing medical devices. Before your product goes to market, you have to know that it is safe and that you've analyzed and mitigated every risk possible.
The most important standard to know in Risk Management is ISO 14971. I reference it in all my work concerning Risk Management, and you should do the same. (Note: if you are developing for the European market, use EN ISO 14971:2012. It is essentially the same standard, but has a few important annexes.)
The Process of Risk Management
Medical device Risk Management requires top management involvement and that a company establish a Risk Management Policy.
The process itself includes:
- Risk Management Planning
- Risk Analysis
- Risk Evaluation
- Risk Controls
- Overall Residual Risk Acceptability
- Risk Management Report
- Production & Post-Production Information
The infographic below align directly to the ISO 14971 standard and is a high-level overview of Risk Management process.
If you are developing medical devices in this day and age, you absolutely must have an established Risk Management process defined, documented, and implemented.
Risk Management is an Enterprise-wide Process.
Risk Management needs to involve more than just engineers and product developers.
You need to include end-users, marketing, sales, business development, quality, regulatory, and manufacturing on your product Risk Management team.
All of these functional areas provide different perspectives and experiences for the medical devices you are designing, developing, and manufacturing.
It is important to ensure your Risk Management efforts are holistic.
Risk Management Starts at the Beginning
Risk Management is not a checkbox activity. If you don't take Risk Management seriously, you could endanger the end-users, which defeats the purpose of creating a medical device in the first place.
From day one, start your Risk Management process. Incorporate it closely with your Design Control process to increase efficiency and fully develop your products safely.
Jon Speer is the Founder & VP of QA/RA at greenlight.guru, a software company that produces beautifully simple quality and risk management software exclusively for medical device companies. He is also the founder of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance & project management.