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Quality and Certification

A display of willingness

 

With its constant desire to meet the most stringent requirements, Mecalectro's approach strives towards continuous improvement.

That is why, since 1993, our quality system has been certified according to ISO9001.

In addition and since the end of the 90s, Mecalectro has been environmentally aware and has had ISO14001 certification since 2002.


Download our certifications here
ISO9001 ISO14001IN9100

 

Specific requirements of the medical sector

These fall under the European directives for medical devices:

Directive 93/42/EEC "Medical Devices"
Directive 90/385/EEC "Active implantable medical devices"
Directive 98/79/EC "In-vitro diagnostic medical devices"

The electromagnetic safety and compatibility requirements for electro-medical devices are covered by these directives. There are a series of specific European standards dealing with the safety of electro-medical devices. The transposition and implementation of medical device directives in Belgium comes under the jurisdiction of the FPS for Public Health, Food Chain Safety and the Environment.