Transforming Health Care:The Drive For Digital Health and Health IT

Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space……

5 Thoughts on Harmonization of Quality Regulation

FDA wants to align its quality system regulation with ISO 13485:2016. Global regulatory experts share their thoughts on what this harmonization could mean for regulatory bodies and the medical device industry……

Supply Chain Readiness for 2022: Re-Assessing and Rebuilding your Suppliers

Embarking on a digital transformation in a post-COVID world will be critical for medical device manufacturers……

FDA Warns of Pediatric Feeding Tube Strangulation

FDA has received reports of two toddlers who died after being strangled by the their enteral feeding tube……

Medtronic Accused of Stealing Business from Globus Medical

Medtronic denies any wrongdoing, but Globus Medical has filed a lawsuit accusing Medtronic and four sales reps (formerly Globus reps) of stealing business……

阅读更多

Medtronic Recalls Atherectomy Device After Patient Injuries

At least 55 patients have been injured from a catheter tip breaking off during procedures to clear blocked arteries……

7 Basic Tools That Can Improve Quality

While companies have adopted different methods to control design and manufacturing outcomes, the intent is always the same: quality improvement……

Benefits of ISO 13485 Certification for Medical Device Manufacturing

ISO 13485 certification is an internationally recognized standard for medical device companies involved at any stage of a product’s lifecycle. Here are some of the many reasons why organizational leaders choose to get their companies certified……

FDA Revokes EUAs for Certain Non-NIOSH-Certified Respirators

The agency action includes all non-NIOSH-approved disposable respirators, including imported KN95s……

The Struggle Is Real: Managing Medical Device Risk

A recent Greenlight Guru survey found that 42% of medical device professionals worry about product risk outside of their work day. Here are some other troubling findings in the report……