to market globally
The medical industry is rapidly adopting new technology that enables better communication and performance of products & systems to improve the safety of care. Manufacturers today, face a number of compliance challenges, as devices that do not meet the highest quality and safety standards present, a risk of injury, recalls, bans and liability.
In this webinar series, you'll gain insights into technical requirements, the standardization process, developments of IEC 60601-1- family, steps the manufacturer must perform fulfill risk management requirements, new methods of risk analysis, navigating the FDA's device approval process, new immunity requirements to mitigate electromagnetic interference and best practices in determining & mitigating potential adverse events of radio frequency identification (RFID) emissions on electronic medical devices.
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In the first webinar of the series, we'll cover the IEC 60601-1 3rd Edition, which has introduced new safety concepts in the form of risk management and intended use environments according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments. These concepts introduce new documentation requirements throughout the manufacturing process and careful consideration of a device's intended end-location to determine an appropriate level of hazard mitigation. If you would like to receive more info on testing & certification, please click here.
to market globally
It is imperative for everyone involved with product design to fully understand how the process of risk management and intended use environments incorporates with new requirements to achieve compliance.
In this Medical Compliance Webinar, you'll get an in-depth overview of IEC IEC 60601-1 Edition 3.1 (IEC 60601-1:2005+AMD1:2012) with critical insights into product safety requirements, risk management principles, and manufacturer's responsibilities from MET's medical device testing experts including: