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…
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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 …
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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 …
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ISO 14971

Considered the internationally accepted standard for the medical device industry, ISO 14971 is a guide for risk management of medical device manufacturing.
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