Customer satisfaction
is our goal

E

motec has extensive experience in the medical device industry, since it’s founding in 1983, has as main objective the total satisfaction of the customer.

The ability to provide a wide range of finished or customized products according to customer design, adding the ability to offer comprehensive services for the development and certification of the Medical Device, pose Emotec among the highest quality in design, development and management of wellness products and health.

Francesco Schittini • Managing Director

Our services

Thanks to the experience and technical training in the field, Emotec is qualified to provide technical support and services.

Registration of the quality system according to the standard

UNI EN ISO 9001-2012

Customer support up to issue the CE certification for medical devices for the risk classes I and II, also preparing for the technical file in accordance with the MDD requirements.

Production and processing in OEM Medical Device.

Packaging of pharmaceuticals and medical devices behalf of third parties.

A cutting-edge production facility

All production is carried out in the White House, where the strict control of particulate and microbiological contamination allows to operate in class “10,000” ISO 7 and pack products in class “100,000” ISO 8.

In them a continuous on-line control, during the various stages of processing and a statistical check on the finished product, guarantee the high quality standard of Emotec.

Emotec was born in 1983 as a company contract manufacturing of important leading companies in the biomedical field located in Mirandola (global pool of manufacturing medical devices).

In 1999 he received the CE mark in order to develop, assemble and sell internationally, medical devices produced. In 2003 he received the AIFA authorization as a pharmaceutical workshop, diversifying its initial core business and building relationships of trust and reliability with important companies operating in the pharmaceutical sector.

The fast and flexible production combined with an established presence and professional service on biomedical global market enable it to increase and diversify their product lines into new areas of application.

Certifications

Certificate CE - IMQ SpA

No CE certificate. 1715 / MDD
the quality management system approval

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ISO 9001:2008

Quality standards-compliant system
UNI EN ISO 9001:2008

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ISO 13485-2012

Quality standards-compliant system
EN ISO 13485-2012

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