“Risk Management is one of the major changes [in ISO 13485:2016]. Risk Management activities are required throughout the QMS and many manufacturers will have work to do to come up to the level of Risk Management that is now required.”
— Kimberly Trautman, Executive Vice President, NSF Health Sciences,
Medical Device International Services
As a device professional, you know you have to perform risk management.
And to do it, many firms start by implementing the international standard for risk management, ISO-14971:2007.
However, this implementation became more complicated when the European Union (EU) objected to the international version and harmonized EN ISO 14971:2012. Since it is more restrictive, this has become the global de facto standard.
But, the additional requirements don’t always align with other standards and there are still misunderstandings about some of the content deviations and terms. This only promises to get worse when the EU rolls out new regulations to replace the current directives which will require a major revision to EN ISO 14971:2012!
Another major change comes with ISO 13485:2016 and its stronger emphasis on risk management activities. This new QMS standard, coupled with the planned Medical Device Single Audit Program (MDSAP), promises a fluid situation for the next few years.
Now is the time for device manufacturers to learn how to put these pieces together and to build a comprehensive and compliant system without becoming overwhelmed
Make plans today to attend, Medical Device Risk Management: Putting the Pieces Together. Limited seating exists for this always in demand FDAnews workshop led by Dan O'Leary, one of the industry’s chief risk management gurus and an esteemed instructor.
Past attendees to FDAnews conferences have raved about working with Dan:
“Great workshop. Dan does a really great job of covering the content but also manages additional requests for information and questions.”
“Dan presented a very interesting course with great dynamics, examples and encouraged group discussion often.”
“The concept of risk management is now understood differently than simply doing FMEA.”
“Dan is very knowledgeable in his subject. I learned a lot that I can use back at the firm.”
“Very knowledgeable in not only the regs/stats but how to implement them.”
“I enjoyed Dan’s appreciation of risk management and his examples from various companies.”
Here's what Dan will have in store for you when you attend Medical Device Risk Management: Putting the Pieces Together. In two action-packed days, you will learn:
- The fundamental concepts of risk management
- The regulatory structure including the US, Canada, and the EU
- The expanded role of risk management in the new Medical Device and In-vitro Diagnostic regulations
- Review of recent FDA Warning Letters – how to avoid these problems
- The process flow in the international standard, ISO 14971:2007
- The relationship between the Risk Management System and ISO 13485:2016
- The details of the EU variant, EN ISO 14971:2012, and how to implement it
- The role of production and post-production information including linkage the EU’s Requirements for Clinical Evaluation
- How to link product and process standards into the Risk Management System
- How to use product safety standards to reduce risk management workload
- How to link FDA guidance documents into the Risk Management System
And, as always, Dan will employ exercises throughout the two days to demonstrate effective risk management. You’ll get out of your seats and actively participate with your colleagues in more than 20 challenging hands-on exercises.
Let's face it: today it's no longer good enough to understand the basics of risk management. You must be knowledgeable about how to build, maintain and audit risk management programs.
So, plan now to attend this two-day workshop and you'll soon be ready to set up a new comprehensive risk plan — or pick an existing one apart to make it better.
Do it now. Putting these programs in place assures that your company will develop safe and effective products … achieve competitive standing in the marketplace … and do it all with the confidence that you are fully complying with FDA and other international regulations.