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Electro-Medical Devices (EMD)

Electro Medical DevicesElectro-Medical Devices (EMD) can be used for Therapeutic (e.g., surgical instruments, lasers) or Diagnostic (e.g., imaging equipment, monitoring devices) purposes.
Stand-alone software, provided it meets the definition of a medical device, can also fit the EMD category.

Challenges

Electro-Medical Devices are covered by the Medical Device Directive (MDD; 93/42/EEC) and are subject to classification rules 9 to 11, plus special rules. Manufacturers must adhere to a specific series of standards, including the IEC 60601 series, which is currently in a transition phase toward its “Third edition”, presenting some significant challenges.

Additional regulations may apply such as Euratom Directives for devices emitting ionizing radiations or the Machinery Directive (2006/42/EC).

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.

 

Questions?

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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clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

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