Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.
I included some new information about the FDA ASCA Pilot Program (new lab info) and also some about the status of some of the Amendment standards and where the US and EU standards are at in terms of adoption.
Enjoy the presentation. It’s at https://youtu.be/yS0xfFX0VpU – MDG Premium’s special YouTube Channel
By the way I recently joined the MDG premium group and you should too. It’s a great way to meet others in the industry and trade ideas and ask questions of experts in the field.
Need help with the IEC 60601 Amendments, work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator ask 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. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at or through our contact form at https://eisnersafety.com/contact_eisner_safety/.