Join me, Leonard (Leo) Eisner, the “IEC 60601 Guy”,
in a conversation with Subhi Saadeh of Combinate Podcast
as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148 https://bit.ly/LIPostCombinatePodcast148LeoEisner
He really does his research and is a great interviewer. I always find it fun and intriguing to have a conversation with Subhi as I too learn from our conversations.
We discuss:
☞ complexities in assessing applicable standards
☞ understanding the impact of product environment, intended use, & applicable markets
☞ challenges and strategies for documenting standards assessments
☞ leveraging existing standards to avoid unnecessary development
☞ tips for small and large companies
☞ significance of early research
☞ essential stakeholders involved in standards assessment
☞ and more….
Join us 🫵 in the conversation on LinkedIn and leave your comments so we can continue this discussion.
Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.
We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.
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