Moving products
to market globally

Achieving product compliance is hard with evolving technology & expanding world

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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Moving products
to market globally

Why 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:

  • Requirements 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.

About
Eurofins | MET Labs

    • Eurofins MET Labs is a gloabal service leader for regulatory certification of electrical products for the worldwide marketplace with 60 years of safety experience to get your products approved and to market faster. MET Laboratories is headquartered in Baltimore, Maryland, with office locations in Union City and Santa Clara, California; Austin, Texas; Cary, North Carolina; and wholly-owned international locations in asia-pacific.

      Eurofins MET Labs performs product safety testing & certification for virtually any market and product safety standard to help you bring the best product to market quickly, responsibly, and cost-effectively. As the first OSHA-recognized NRTL (Nationally Recognized Testing Lab), a CB (Certification Body) for the SCC (Standards Council of Canada), and a CAB (Conformity Assessment Body) & CBTL under the IECEE CB Scheme.

      The MET Mark for product safety is accepted throughout the United States & Canada and indicates compliance to federal regulations for safe use in the workplace. 30 years ago, MET became the first OSHA-recognized NRTL (Nationally Recognized Testing Laboratory) in the United States. The NRTL mark is required under federal law for products used in workplaces in all 50 states. MET listed products are also sold in every major retail stores throughout the United States and Canada.

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