FDA Registered

EMCI is an FDA registered manufacturer, fully compliant with all FDA QSR requirements.

FDA QSR covers a wide array of compliance issues. Below are some of the areas of compliance required by FDA QSR.

ISO 13485:2003 & 9001:2008

EMCI is certified to ISO 13485:2003 and 9001:2008 standards.

From our certification: Epic Medical Concepts & Innovations has been assessed and deemed to comply with the provisions of [ISO 13485:2003, ISO 9001:2008] in respect of scope of operations given below:

The design, development, manufacturing, distribution, and servicing of active and non-active surgical instruments for reconstructive and plastic surgery.

Quality Resources

Please visit the resources listed below to learn more about quality systems.

NOTE: EMCI is not responsible for content on 3rd party websites.