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Achieving product compliance is hard with evolving technology & expanding markets

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-x family, steps the manufacturer must perform to 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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Series line up

The latest, 4th edition of the collateral standard IEC / EN 60601-1-2 brings with it far-reaching changes to both the planning and implementation of the compliance process. While the immunity level requirements are more onerous for all medical devices, requirements now also differ based on the environment of intended use.

In Part 2 of this Webinar Series, you'll gain insights into technical EMC requirements of IEC/EN 60601-1-2, use environments, manufacturers' risk management responsibilities, product planning, and best practices for determining & mitigating interference and device malfunction If you would like to receive more info on testing & certification, please click here.

Moving products
to market globally

Why to attend

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 Part 2, learn critical insights into technical EMC requirements of IEC/EN 60601-1-2, Use environments, Manufacturers' Risk Management responsibilities, Product planning, and Best practices for determining & mitigating interference:

  • Reguirements of IEC 60601-1-2:2014/EN 60601-1-2:2015 4th edition
  • Compiling a risk management file – necessary components, documentation procedures, manufacturer due diligence.
  • Use environments – Professional healthcare facility environments, home healthcare environments, and special environments.
  • Manufacturer responsibilities - Safety requirements, Test plan requirements, and Markings & Identifications.
Achieving Product Excellence
  • Risk management and compliance – Why you need to understand ISO 14971 to properly perform your risk management requirements.
  • Product Planning – Properly evaluating the impact of use environments on your product, steps to delivering a compliant product to market.

Eurofins | MET Labs

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