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Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers

Date: Tuesday, June 25, 2024  

Time: 11:00 a.m. - 12:00 p.m. ET 

About this event

Join us for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Learn about the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.

What will you learn? We’ll answer some of the most pressing questions, such as: 
 •    How North American medical device manufacturers can leverage the CB scheme and its benefits.

 •    Examples of medical devices BSI can certify.
 •    Key changes introduced in the latest edition of IEC 60601-1 Ed. 3.2: 
Clause 7, Identification and marking.
       o    Clause 8, Protection against electrical hazards.
       o   Clause 13, Hazardous situations and fault conditions.

Why Attend?
 •    Gain insights into how the CB Scheme can benefit your organization.                                                                   •    Understand the scope of the BSI CB Scheme and its relevance to your devices.
 •    Prepare for the transition to IEC 60601-1 edition 3.2 and stay ahead of regulatory changes. 
 •    Learn best practices for leveraging the CB Scheme for efficient market access.

Who Should Attend? 
 •    Medical device manufacturers in North America.

 •    Regulatory affairs professionals.
 •    Quality assurance professionals.                             •    Anyone involved in the certification of medical devices. 

Secure your spot today and unlock the potential of the CB Scheme for your medical devices.


Leo Eisner

Leonard (Leo) Eisner is the founder of Eisner Safety Consultants and an expert in the standards development process, staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.
He is also an expert member of development teams on IEC 60601-1, edition 3.2 (via IEC TC62/SC 62A/MT28 & MT30 & WG14 & IEC TC62A/Ad Hoc Group 62368-60601) and 4th edition of IEC 60601-1.

Holly Rossington 

Energy Commercial Manager - BSI Group

Please register for this meeting by providing the information requested. You will receive confirmation of registration soon after completion. 

Thank you for your interest in our webinar.


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