Live Webinar IEC 60601-1, Ed 3.1 The new paradigm for Medical Device Safety

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By Mike Colvin Ph.D have over 100 domestic and International patents issued."

Medical electrical equipment-requirements for basic safety and essential performance

Description

Free documents/Article/ebooks/sops/checklist for Attendee:

The medical device/equipment field is one of the most heavily regulated industries, for obvious reasons.  Medical equipment are an important tool in efforts to improve patient care and treatment outcomes. However, today’s advanced medical devices usually consist of unique combinations of mechanical, electrical and electronic components and technologies that are frequently controlled by software or programmable controllers. As a result, international regulations and standards applicable to medical devices are being continuously revised and updated to reflect potential safety issues that can result from increasingly complex device designs.
First published in 1977 by the International Electrotechnical Commission (IEC), IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, is the internationally recognized standard addressing general requirements for medical electrical equipment and devices. IEC 60601-1 has undergone a number of significant revisions over the years in an effort to remain current with new and advanced medical technologies. The latest set of changes was introduced with the 2012 publication of Amendment 1 to IEC 60601-1.
This webinar provides an overview of the IEC 60601. It also covers the modified requirements presented in IEC 60601-1 Edition 3.1. Beginning with a brief summary of the history of the standard, the webinar then offers a review of the significant additions and changes presented in Amendment 1, as well as information on other changes that may affect medical device manufacturers.

Why should you attend : 

This Webinar is geared toward those who require a working knowledge of ISO 60601-1 Ed 3.1

Areas Covered

The areas that will be discussed in the webinar will include the following topics:

•     History of IEC 60601-1
•     Overview of collateral standards , i.e., IEC 60601-1-XX
•     Overview  of particular standards, i.e., IEC 60601-2-XX and IEC/ISO 80601-2-XX
•     Brief review of ISO 14708, Active Implantable Medical Devices, ISO 61010, In-Vitro Diagnostics
•     Review of 14971 Risk Management File
•     IEC 60601 Ed 3.1 
           o Protection against electrical shock, and verifying electrical insulation
           o Protection against mechanical hazards
           o Protection against thermal and other hazards and components

Who will Benefit

•     Medical Device industry Managers, Supervisors, Employees,
•     Electronic  Industry Managers, Supervisors,  Employees,
•     Quality Assurance Personnel,
•     Technical Consultants

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Mike Colvin Ph.D.

Mike has over 30 years experience developing medical devices and systems. Over his career he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and start ups.

Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology.

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