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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.

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