Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an increased risk to patient safety and product efficacy. Software architects face difficult decisions regarding product development and patient safety. Medical Devices: Five Principles to Keep Up with…

Sterling Medical Devices’ Cybersecurity Expert, Keith Handler, Interviews with Lee Neubecker of Enigma Forensics in a 3-part series on Cybersecurity in Medical Devices

Our Cybersecurity Expert, Keith Handler, provides insight into the challenges that medical device developers and manufacturers face today. Cybersecurity regulations and preventative measures are the focus in the 3-part series with Enigma Forensics. Medical Device Security   As an ISO 13485 certified medical device development company, Sterling Medical Devices always makes safety a top priority.…

Why Cybersecurity is Becoming More Important in the Medical Device Industry

Cybersecurity in the medical device world has evolved from a footnote to a front-page headline. Articles with titles like “Medical Devices are the Next Security Nightmare” (Wired) and “Medical Devices… Lethal in Hands of Hackers” (The Hill) worry device manufacturers, doctors, and patients alike. These concerns are a direct result of an increasingly interconnected medical…

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

The Effective Software FMEA Risk Management Approach Software FMEA, (Software Failure Modes and Effects Analysis) is a method of risk management that identifies single-fault failure modes in software design and code engineering. During software development, FMEA is applied to prevent possible defects and to ensure the software system safety works predictably. Factors like missing software…

FDA 483

Understanding Form FDA 483 Observations   The FDA conducts inspections on Class II and Class III medical device companies either for pre-approval before products are cleared for release, impromptu routine 2-3 year checks, or “for-cause” inspection related to a specific report. These inspections can make or break the integrity of a company, especially startups that…