This webinar introduces a new tool for documenting both product risk management and design controls in a combined planning template.
Combining Risk with Design in a Traceability Matrix
Addressing design controls and risk management requirements separately is no longer an option. When design controls were first required, 1994 for ISO 9001 and 1996 for the FDA, there was no medical device risk management standard yet. ISO 14971 was first released in 2000, and the risk management process needs to be integrated with your design process. The webinar will teach you how to combine risk with design in a simple traceability matrix. The matrix also addresses the challenging expectations for CE Marking. This tool can also be applied to other products that are pharmaceuticals, biologics, combined drug/device products, and non-medical products.
The Failure Mode and Effects Analysis (FMEA) has been used for decades as the most popular tool for documenting risk analysis. The FMEA remains the best tool available for process risk analysis, but it does not adequately satisfy the “state of the art” requirements for risk management of medical device design and development. A new approach is needed.
In this presentation, our speaker reviews the global regulatory requirements for risk management and design of medical devices—including EN ISO 14971:2019 and the European Medical Device Regulations. You will also learn how to perform post-market surveillance and post-market clinical follow-up studies to ensure that risk management remains effective.
Join us for this webinar as our speaker helps you combine your product risk management activities with your design and development process.
This product risk management webinar shows you how to combine risk with design controls:
- Requirements for design history file & risk management file
- Scheduling risk management as part of design plan
- Possible tools for risk assessment
- An alternate risk management solution for improved hazard traceability
- Post-Market Surveillance requirements and Writing an IFU
Are you interested in product risk management training?
If you are interested in training specific to risk management or design controls training, please visit the following pages:
Who should watch this webinar on combining risk with design?
- Anyone Responsible for Design Controls
- Anyone Responsible for Product Risk Management
Please Note: Purchase of the webinar includes the Native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.
This webinar recording is only $129 (AND INCLUDES – SLIDE POWERPOINT PRESENTATION):
Exam and Training Certificate available for $49.00:
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About Your Instructor
Rob Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others.
Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone at 802.281.4381 or by email.