What Standards Apply to My Device? Podcast #383

What Standards Apply to My Device? Podcast #383

๐—ช๐—ต๐—ฎ๐˜ ๐—ฆ๐˜๐—ฎ๐—ป๐—ฑ๐—ฎ๐—ฟ๐—ฑ๐˜€ ๐—”๐—ฝ๐—ฝ๐—น๐˜† ๐˜๐—ผ ๐— ๐˜† ๐——๐—ฒ๐˜ƒ๐—ถ๐—ฐ๐—ฒ? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru’s very own

๐—ž๐—ฒ๐˜† ๐—ง๐—ผ๐—ฝ๐—ถ๐—ฐ๐˜€:โ€ผ๏ธ
โ€ข Why standards like IEC60601 are crucial for medical device development
โ€ข Steps for identifying proper standards for your product
โ€ข How to integrate standards into your design process
โ€ข Mistakes & consequences of ignoring standards
โ€ข Tools for staying updated on changing standards & regulations
โ€ข How startups can navigate standards with limited resources

How to ID Applicable Standards – Combinate Podcast

How to ID Applicable Standards – Combinate Podcast

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

FDA Announces Consensus Standards Guidances, Podcast & Webinar

FDA Announces Consensus Standards Guidances, Podcast & Webinar

On September 13, 2018 the FDA posted 2 Guidance Documents Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance Podcast on Standards & FDA’s Release