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

Thought and Commentary for the Medical Device Industry

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Quality Systems (Part 3): Balancing Empowerment vs. Control

June 10, 2019 | Posted by Randy Armstrong
In the 3rd part of this series, we address how to balance empowering a design team to create a medical device that provides safe and effective therapy or diagnostic, while still ensuring adequate...

Quality Systems (Part 2): Developing a Lean QMS

June 3, 2019 | Posted by Randy Armstrong
Implementing a lean QMS is not about cutting corners. It is about corporate focus, which in our case means being risk-driven to create safe and effective devices as quickly and cost-effectively as...

Quality Systems (Part 1): Introduction to Lean QMS

May 27, 2019 | Posted by Randy Armstrong
In the medical device industry, every company knows the necessity of a Quality Management System (QMS) for managing internal processes and tracking work to regulatory requirements. Many companies...

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:

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