US FDA Recognizes New Cybersecurity Standard UL 2900-2-1

What does it mean for the Medical Device industry? The current ever-changing landscape of cybersecurity threats and hazards, amongst ransomware campaigns and remote vulnerability cracks, call for medical device manufacturers to better prepare their products for lifetime security. Regulations are pushing manufacturers to ensure that their products stay secure long after they are taken off…

Software FMEA

CAPA issue resolution assistance

ISO 14971

Device Engineering

FDA 483

Gap Analysis

Bridging the Gap between Good to Even Greater   All medical devices and software are required to undergo a series of mandatory safety testing in order to satisfy standards such …

Sterling Medical Devices Sponsors Depuy Synthes Golf Outing Fundraiser

On September 19, 2016, Sterling Medical Devices sponsored and participated in Depuy Synthes 3rd Annual fundraiser event.. The proceeds from the golf outing fundraiser at the Honeybrook Golf Club in …