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……

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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……

Dirty Bronchoscopes are a Bigger Problem Than Ever

FDA received 867 reports related to infections or device contamination associated with reusable flexible bronchoscopes between July 2015 and January 2021. The agency just updated its guidance for reprocessing these difficult-to-clean devices……

How to Achieve Quality through Process Validation

With any manufacturing process, you want certainty in the quality of your products. As you scale production from hundreds or thousands into the millions, you want to know with a high level of confidence that your process produces good parts with consistency……