On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...

ALACHUA, Fla., Jan. 26, 2026 /PRNewswire/ -- Amend Surgical, a medical device company focused on novel products for oral wound-care and regenerative biomaterials, today announced that it has achieved ...

I oversee all our coverage of lifestyle topics, which include cleaning, organizing, wellness, entertaining, real estate, travel, and more. I’m based in Honolulu, Hawaii. We independently select these ...

Are you ensuring your medtech products meet customer and regulatory requirements. ISO 13485 is the regulatory standard for MedTech Quality Management Systems. It emphasizes the importance for medical ...

Brendan Carroll, Jessica Ritsick, Jong Ho "Philip" Won, Ph.D. Our FDA: Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

ANN ARBOR, MI / ACCESS Newswire / November 6, 2025 / Zomedica Corp. (OTCQB:ZOMDF) ("Zomedica" or the "Company"), an animal health company offering innovative point-of-care diagnostic and therapeutic ...

The U.S. FDA’s attempts to harmonize with other nations on quality management received a dose of good news recently when the International Organization for Standards decided to stand pat on ISO 13485, ...

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. We've mastered ISO 13485, understood CFR 820, and navigated EU MDR ...

Performance reviews are nerve-wracking for everyone. Career decisions and remuneration may hang in the balance. You want your manager to see your past year’s accomplishments the way you see them. So ...

Ever feel like your computer desktop is a digital jungle? Or that your cloud storage is more chaotic than your junk drawer? In our hyper-connected world, digital clutter builds up fast—and it can ...

BOULDER, Colo. – Boulder Sterilization, part of the Boulder BioMed family, has received 13485:2016 certification from the British Standards Institute (BSI) for its chlorine dioxide service. The ...