Articles by Jon Speer
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The Design Controls + Risk Management Connection — Intended Use & User Needs
10/19/2015
Design controls and risk management should flow and blend together, and it’s important to establish this flow early in product development - some companies treat them as related but separate processes, not realizing the close connection. Intended use is the gateway to user needs, design & development plan, design inputs, risk management plan, hazards, hazardous situations, and foreseeable sequence of events.
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5 Tips For Better Medical Device Risk Management
9/15/2015
During my 17+ year career in the medical device industry, the emergence and sudden importance of risk management has been the most striking phenomenon. I could take you through my own personal risk management history lessons but will spare you the boring details. Instead, I want to do my best to get you as up to speed as possible with respect to risk management.
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Stop Treating Risk Management & Design Controls As Checkbox Activities
9/1/2015
Understanding the relationship between product risk management and design controls is critical to the success of a medical device in the marketplace. Both are all too often treated as “checkbox” activities that have to be done because the regulations say so. Read on to see why you should embrace design controls and risk management not just as necessary evils, but as tools to help ensure your medical device is as safe and effective as possible.
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5 Tips To Help Your FDA 510(k) Submission (Checklist Included)
7/16/2015
If you are developing a medical device in the United States, there is a good chance your path to market involves a FDA 510(k) submission. Within the past year, I’ve had the pleasure of authoring a couple FDA 510(k) submissions on my own from scratch, and I have learned a ton from these experiences. FDA expectations for 510(k)s are dramatically different from when I started my career. Let me share some things I’ve learned.
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The Art Of Medical Device Design Inputs
4/27/2015
Design inputs are the foundation of medical device development. And without a strong foundation, bringing a new product to market can be problematic.