GMED North America’s Training Center

Medical Device Electrical Safety

Understand the electrical safety requirements per IEC 60601-1 A1/A2
2-day training session (split over 3 consecutive half-days of training) | Virtual Classroom

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About the training

GMED North America has created a 2-day training session, to equip medical device manufacturers with the right strategy to ensure their Medical Device Electrical Safety processes can withstand heightened scrutiny from NBs.

This comprehensive 2-day course covers the general details of the standard and features numerous built-in knowledge checks that allow learners to apply and reinforce the new concepts throughout the training. Designed to build a solid foundation, the course explores key aspects of the standard including its general philosophy, scope, structure, evolution, adaptation for use as national standards, the use of risk management, and the requirements for markings and accompanying documents.

Ali Homaida Senior Compliance Engineer – Active Medical Devices at 601 Consultancy Ltd

Ali Homaida is an accomplished IEC 60601-1 Compliance Engineer, Consultant, Product Reviewer, and Trainer in the medical device industry.

With a background in biomedical engineering, he has worked with test houses in compliance assessment of electrical medical devices including safety testing, risk management files evaluation, usability engineering, and medical devices software.

Who Should Attend

Medical Device Manufacturers: Quality Assurance Specialists, Regulatory Specialists, R&D Engineers, Risk Management Team Members, and Product Specialists
Auditor and Product Reviewers for Active Medical Devices

Learning Objectives

Determine the applicable medical equipment requirements to design products for compliance
Define insulation parameters and requirements
Determine creepage, clearance, insulation thickness and dielectric strength requirements
Identify appropriate grounding / earthing, fire protection and mechanical requirements
Create accurate and concise design and purchase specifications for critical components to achieve safety compliance goals
Identify performance testing, marking, documentation requirements
Learn the additions/differences brought by Amendment A2 (2020)

Educational Resources

Presentations
Practical working sessions
Course evaluation

Check out the Program

The normative architecture applicable to electromedical devices

Introduction
Definitions and vocabulary
Basic Safety and Essential Performance Aspects
Classification of ME EQUIPMENT and ME SYSTEMS
Markings and Documentation Requirements
Protection against electric shocks
Critical Components
Power Supply and Batteries
Mechanical Hazards
Protection against unwanted and excessive radiation hazards
Protection against excessive temperatures
Accuracy of controls and instruments and protection against hazardous outputs
Hazardous situations and fault conditions
Programmable Electrical Medical Systems (PEMS)
Construction of ME Equipment
Construction rules
Medical Electrical System (clause 16)
Amendment 2: IEC 60601-1:2005/AMD2:2020

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