GettyImages-509731276

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

Thought and Commentary for the Medical Device Industry

show all

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part V - Trustworthy Devices (Cont'd)

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.

A Summary of Medical Device Standards - Part IV - Digging Deeper: How to be Compliant

March 28, 2019 | Posted by Tim Carroll
Part 820 is wide-reaching. In order for a medical device company to fully understand what compliance with Part 820 means, further elaboration is required. Two of the most important areas this...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part IV - Trustworthy Devices (Cont'd)

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.

A Summary of Medical Device Standards - Part III - Earning (And Keeping!) FDA Approval for Your Device

March 21, 2019 | Posted by Tim Carroll
FDA approval can be achieved in two ways: The 510(k) process, in which the manufacturer must provide evidence that the device they intend to market is “substantially equivalent” to a device...

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

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. 

A Summary of Medical Device Standards - Part II - Understanding CFR Part 820

March 14, 2019 | Posted by Tim Carroll
CFR Part 820, often referred to as simply Part 820, delineates the requirements for a quality management system that must govern the design and manufacture of any device sold in the United States....
iStock_76972749_XLARGE

Get Started On Your Next Project

PARTNER WITH US