Helmer, Inc. received ISO 13485:2003 certification for the design, development, manufacture, sales, and service of biological material storage and processing equipment. ISO 13485:2003 certifies:
- an organization consistently demonstrates its ability to provide medical devices and related services that meet both customer expectations and regulatory requirements
- there are controls in the work environment to ensure product safety
- risk management activities are implemented during product development
- specific requirements are set for the verification of corrective and preventive actions
This certification demonstrates Helmer's commitment to quality management and assurance, and bears witness to the care and responsibility put into the design and manufacture of Helmer products. ISO 13485:2003 is becoming widely accepted as the international standard to address medical device regulations around the world.
Certification Organization: BSI Management Systems
Certificate Number: FM 536286
Registration Date: 4/14/2009
About Helmer:
Helmer is a manufacturer and distributor of Storage and Processing Equipment for the Clinical Market. Our products include blood bank, laboratory, and pharmacy refrigerators; plasma and laboratory freezers; platelet storage equipment; plasma thawing system; and centrifuges. Our world headquarters is located in Noblesville, IN, with distribution throughout the world.
