Icentia announces that it has received certification from the British Standards Institution (BSI) that its quality system meets the ISO 13485:2003 standard for medical device product.
Beginning of 2014, Icentia embarked on an effort to enhance its quality and manufacturing capabilities to the level necessary to meet the regulatory requirements for manufacturing of medical devices. On April 30th, BSI certified Icentia as meeting all the requirements of the standard.
“Obtaining the ISO 13485 certification in such a short period of time is a clear demonstration of the talent and strong teamwork of all our employees.” states Pierre Paquet, Icentia co-founder and CEO. “Achieving this important milestone constitutes a key step toward obtaining the Health Canada Medical Device License for the CardioSTAT®.”
ISO 13485 is the world’s most recognized standard for quality management systems for medical devices. Obtaining the ISO 13485 certification is the most commonly chosen path for companies to meet the quality system requirements necessary to manufacture medical devices in Europe, Canada, Japan, Australia, and other countries.
BSI is one of the world’s largest and most trusted independent certification bodies for quality management systems.