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, also known as Software Failure Modes and Effects Analysis, is a specific method of risk management that pertains to identifying single-fault failure modes in software design and code engineering. During software development, medical device FMEA is applied to prevent possible defects that might occur and ensure…

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…

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 as the FDA Quality System Regulations, the EU’s CE Marking Medical Device Directives, or specific ISO standards. Sterling has extended the experience with various editions…

Developing Medical Device Software – Blog

“Developing Medical Device Software,” new Med Device Online article series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device software companies should consider preparing for a potential expansion of this case practice according to Sterling Medical Devices engineering managers, Steve Hartman and Nick Oshman, authors of a…

When Medical Device Software Fails Due to Improper Verification and Validation

Software can be an essential component of your medical device, whether you’re designing a new product or improving the functionality of an existing one. Medical device software continues to change and expand across many types of medical devices. Patient safety must be a primary concern of medical device companies. The FDA continuously monitors and reports…

Is Your Medical Device an Entry Point for a Cyber Attack?

The Internet of Things (Iot), the continual proliferation of mobile medical devices, and the growing amount of data in hospital systems are trends medical device manufacturers should closely follow. Similarly, medical device manufacturers should track cybersecurity trends. Just last year the number of medical device cyber attacks on government systems grew to nearly 61,000*. Because…