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.

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.

IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want.

Can you imagine a future where the question, “Did you bring a copy of your test results?” becomes entirely unnecessary?

‘How is it that in the middle of a relatively small town of about 125,000 people in Minnesota, you’ve got the No. 1-rated healthcare system probably in the world?”