Designing a new product that benefits the society is very rewarding, but it faces multiple obstacles before it can move into production and land in the hands of your end-users.
For most devices, regulatory approval is often required before deploying a product to market. Medical devices are notorious for strict regulatory requirements. One regulatory requirement required for a medical device is a series of technical standards that ensure the safety of medical electrical equipment referred to as IEC-60601 or ISO60601. The IEC/ISO-60601 standard covers safety and performance requirements of medical electrical equipment and public health authorities in many countries rrecognizeIEC 60601-1 as a pre-requisite for the commercialization in different markets around the globe.
THESIS is proud to be a design partner with ARTICARES in developing the first clinically validated, portable arm rehabilitation robot for minimally supervised diagnostics and rehabilitation. ARTICARES’s flagship product – the H-MAN robot is an arm-rehabilitation medical system designed to help individuals suffering from neurological injuries such as stroke.
THESIS worked closely with ARTICARES on the electronic and electrical systems on the H-MAN robot to ensure that documentation requirements for IEC6060-1 approval are met and now the system has been featured in several trade shows and on Channel NewsAsia. THESIS is committed to our client’s business success and our proven 5-step design process has helped ARTICARES push their H-man robot to the market.
Talk to us about how we can help you accelerate your technology and vision to the next level!