Medical Robotics and medical automation will fill urgent needs in health care, but must meet applicable regulations
In most countries, medical devices that have a direct impact on people’s health are subject to strict regulations. Regulatory bodies such as the U.S. Food and Drug Administration and Health Canada require these medical devices meet a minimum level of safety and performance criteria before they can be sold and used.
But applying the requirements of regulatory bodies to cutting-edge, innovative products — like medical robots — can be challenging.
Manufacturers need to be fully aware of how their designs, materials and software could impact their ability to meet relevant standards, such as the IEC 60601 family of medical standards, when the product is considered a medical device.
This case study explores how manufacturers can successfully overcome testing and certification challenges for medical robots.
This case study covers the following topics:
- An aging population and the strain on an overloaded healthcare system;
- Manufacturers’ struggle to comply with regulated IEC/ISO standards; and
- How CSA Group can help manufacturer’s test to required international standards.
Dr. Edgar Sotter, Senior Director of New Product Technology was also invited to speak with other industry leaders at Globalspec Engineering 360 to explore the challenges of machine-to-machine (M2M) systems including, ensuring M2M growth is sustainable for networks, identifying power supplies for mobile, remote and other challenging sensing applications, and managing and applying the big data created by M2M. Watch the on-demand webinar: Machine-to-Machine Communication Challenges on the Factory Floor
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