GOLETA, CALIF. – iCRco, a ISO 13485 certified manufacturer of medical devices, announced today that is has successfully completed its annual ANVISA audit for the third consecutive year. Brazil is the largest medical device market in Latin America, and has an established but complex regulatory system. Medical devices in Brazil are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA).
“The regulatory standards and requirement for ANVISA are the most demanding.” said, Stephen Neushul, President and CEO for iCRco, Inc. “There are a number of reasons why a company would not complete their ANVISA audit. This can be anything from inadequate quality systems, invalid test methods, or lack of investigations of products that fail specifications.”
The (US) FDA is known for being tough but ANVISA is considered the toughest regulatory agency with respect to audits. Few foreign manufacturers are approved by ANVISA, and the region prefers home-made products imported in bulk and then packaged for consumers in Brazil. Since the country is growing as a market for medical devices the demand is expected to pick up. iCRco is currently approved to sell its CR, DR PACS and Mammography solutions in Brazil. It expects to have its full line of iDR digital systems approved later this year.
“This completion of the ANVISA audit, for three consecutive years, is a testament to iCRco’s commitment to quality and regulatory standards." added, Neushul. "The result of the inspection is the continuation of the certification for our CR, DR, PACS and recommendation to grant the certificate for our iDR series.”
In addition to its ANVISA status, iCRco is a ISO 13485 company. The International Organization for Standardization (ISO) represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 is now considered to be inline standard and requirement for medical devices.
About The Company Founded in 1990 by Stephen Neushul, iCRco, Inc. has introduced a full range of digital-imaging solutions to serve medical imaging professionals. Pioneering introductions include the first single-plate digitizer to have True Flat Scan Path™ technology, iCRco now offers a full range of digital-imaging solutions, including CR, DR, cone-beam CT; image-acquisition, practice-management, and image-archiving software.
For more information, contact iCRco at (310) 921–9559 or at sales@icrcompany.com