A wide variety of medical devices incorporate embedded software. Some of these such as: X-ray scanners, heart rate, blood pressure and breathing monitors, are used for analyzing patients. Others such as defibrillator and medication pumps, are used to treat patients. In both cases, people’s health and safety depend on the medical software deployed being reliable, safe and bug-free. The other aspect is medical app which can facilitate physician’s decision, diagnose symptoms, or give suggestion to treatment. The International Electrotechnical Commission created the IEC 62304 standard which outlines the requirements for medical software life cycle process.
What are the key points of IEC 62304 standard? What are the tips for developing medical software regarding to this standard?
On our very first Regulatory webinar, held on February 8th, we answererd these and many other questions.
Video recording from eHealth HUB Regulatory webinar is now online, freely accessible, at the following link: