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Blog

Thought and Commentary for the Medical Device Industry

Transformational Leadership - Acknowledge Who You're Not

April 22, 2019 | Posted by Dan Purvis
It may feel counter-intuitive, but referring potential clients to companies that operate just outside your specialty or overlap with you can actually be a great way to build your network, develop...

Agile Development for Medical Devices - Part II

April 18, 2019 | Posted by Jason Swoboda
Our last agile development post focused on the big picture: when, how, and why to depart from the classic waterfall development model in favor of lean and agile practices. But what does that look...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part VII - Cybersecurity Documentation Required for Submission

April 15, 2019 | Posted by Ben Trombold
Welcome to the final installment of our breakdown of the new FDA cybersecurity standards In this post, we’ll look at required documentation manufacturers need to include in their premarket...

Agile Development for Medical Devices - Part I

April 11, 2019 | Posted by Jason Swoboda

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

April 8, 2019 | Posted by Ben Trombold
Labeling is any written text that identifies any part of a medical device. This includes a label directly on the device, user manuals, instructions for use (IFU), labels present on the outside of...

Quality Management for Software as a Medical Device

April 4, 2019 | Posted by Sean Carroll
Successful quality management for Software as a Medical Device (SaMD) will have 3 preeminent distinctives: