EOS Power Achieves ISO 13485:2016 Certification

EOS Power is proud to announce that it has received certification for ISO 13485:2016, a Quality management system for medical devices.

The certification was granted by LL-C Certification, Czech Republic.

 

 

EOS Power is engaged in the design, manufacturing, and selling of Medical grade power supplies. EOS Provides standard, modified and custom design power solutions to customer needs. All Medical grade power supplies are approved to the latest medical certifications required globally and now in addition EOS Power design process, manufacturing and quality systems are certified to ISO13485 standards.

This allows EOS Power to become a “one-stop” solution for medical device manufacturers for their power supply and any EMS/PCBA requirements required in their medical application.

 

• LL-C Certification is a global certification body for testing, inspection, and certification (TIC) services and is headquartered in Prague, Czech Republic.
• LL-C certification has achieved accreditation by ANSI National Accreditation Body.
• LL-C certification body has a presence in more than 70 countries and has issued more than 13000 certificates.

 

ISO 13485:2016 standard is recognized by the Global Harmonization Task Force (GHTF) and has become the model QMS standard for the medical industry. ISO 13485:2016 certification provides:

 

• Global Recognition – ISO 13485 Standard is recognized in major markets around the world
  • United States of America
  • Europe
  • Canada
  • Japan
  • Australia
• Meets legal, regulatory, contractual and marketing requirements.
• An ISO 13485 Quality Management System (QMS) which is very close to the Food and Drug Administration’s (FDA) QSR standards.
• Improved product safety

 

“EOS Power’s manufacturing facility obtaining ISO 13485:2016 certification is an advantage when working with Medical customers, allows us to add potential opportunities in the medical device markets we have being missing where this certification was required,” says Mr. Paul Scholz, VP-Sales. This certification provides additional leverage with customers, added Ms. Teresa Fernandez, EMEA Sales Manager.

“Successfully achieving ISO 13485:2016 certification is a huge milestone for EOS Power in its journey of becoming a world-class organization. This will certainly help to position EOS Power as a global leader in the medical device industry” says Mr. Vijay Gujarathi, COO and Director.

 

About EOS Power

EOS Power India Pvt. Ltd., home of the award-winning EOS brand of power supplies and power solution products. Established in 1991 (California USA) from several pioneers in the field of power electronics. EOS developed into a standard/modified standard/custom products company with turn-key design, manufacturing, sales and support operations. Today, the company is the largest manufacturer and exporter of branded power supplies in India and also offers complete VAM, ODM support and repair services in India for its customer partners.

EOS is focused on designing leading edge low to medium power AC/DC power product footprints for the global medical, industrial and other commercial markets. The product designs are robust, high quality and flexible to allow modifications and value add engineering which is more unique in today's limited “off the shelf” solutions.