In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.

This Thursday, for the first Thanksgiving in decades, I won’t be watching football, drinking beer, and stuffing myself into oblivion. Instead, I’ll be serving the homeless, giving clothes, and making myself useful.

Next to defining a problem accurately, root cause analysis is one of the most important elements of problem-solving in quality management.

The NIST Cybersecurity Framework consists of standards, guidelines, and best practices to manage cybersecurity-related risk. The framework’s prioritized, flexible, and cost-effective approach helps to promote the protection and resilience of critical infrastructure a

BioBridge Global (BBG) is a parent organization for four subsidiary organizations, three of which are involved in production activities, and they’re all around regenerative medicine, including blood components, clinical laboratory testing, and cell and tissue therapi

These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S.

The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada.

The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand.

One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years.