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Improving Lives for a Better World, One Device at a Time

Thought and Commentary for the Medical Device Industry

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New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part V

April 1, 2019 | Posted by Ben Trombold
Welcome back to our continued breakdown of the new FDA Cybersecurity guidance. In this post, we will conclude our analysis of the “Trustworthy Devices” section of the document.
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New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part IV

March 25, 2019 | Posted by Ben Trombold
This post resumes our discussion of the FDA’s new cybersecurity guidance for medical devices surrounding the design and development of trustworthy devices.
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New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part III

March 18, 2019 | Posted by Ben Trombold
Designing and developing trustworthy medical devices, according to the new FDA guidance on cybersecurity, will be our focus for the next two posts.
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New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part II

March 11, 2019 | Posted by Ben Trombold
Our first topic concerns classification of medical devices according to the new FDA guidance. Two separate tiers of classification are described:
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New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part I

March 5, 2019 | Posted by Ben Trombold
FDA 2016 Guidance on Cybersecurity within Medical Devices
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