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Electrical Safety and Electromagnetic Compatibility (EMC) of Medical Devices

Picto Electrical Safety and Electromagnetic Compatibility TrainingRequirements of the New IEC 60601-1 (2005) Standard

Course Objectives

This program is designed to provide participants with a variety of knowledge and skills:

  • Understand the European regulations for electrical safety and electromagnetic compatibility applicable to electric medical devices
  • Identify key technical requirements to develop an electrical medical device in accordance with this regulation
  • Understand the compliance verification approach, according to IEC 60601-1 standard

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EN 60601 Guide

LNE G MED CE Marking IVD Medical DevicesWe provide answers to the most important questions, lighting the way through the 3rd edition for manufacturers.

 

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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

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Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

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Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager