Learn from an ๐ถ๐ป๐๐ถ๐ฑ๐ฒ๐ฟ ๐ฐ๐ผ๐บ๐บ๐ถ๐๐๐ฒ๐ฒ ๐บ๐ฒ๐บ๐ฏ๐ฒ๐ฟ that wrote portions of ๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ-๐ญ, ๐ฒ๐ฑ ๐ฏ.๐ฎ ๐๐บ๐ฒ๐ป๐ฑ๐บ๐ฒ๐ป๐๐ and is involved in the development of the Fourth Edition of IEC 60601-1. If you want to learn about these updates to the standard and the IEC 60601 Amendments Project – You’re in luck – Leonard (Leo) Eisner the “๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ ๐๐๐” from Eisner Safety Consultants partnered with Holly Rossington of BSI to present the webinar “Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers”
We answered some of the most pressing questions, such as:
โข How North American medical device manufacturers can leverage the CB scheme and its benefits.
โข Examples of medical devices BSI can certify.
โข Key changes introduced in the latest edition of IEC 60601-1 (Ed. 3.2):
o Clause 7, Identification and marking.
o Clause 8, Protection against electrical hazards.
o Clause 13, Hazardous situations and fault conditions.
And lots more.
Watch to the end to get other valuable resources too!!! ๐ฅ๐๐ฅณ๐โ๏ธ
Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic 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 Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.
Feel free toย schedule a meeting Leoย or contact Leo atย ย or through ourย contact form.