Persistent Systems, a global company specializing in software product and technology services, has obtained ISO 13485:2003 certification from DNV.
The ISO 13485:2003 certification is the international quality management systems standard for medical device software.
Persistent Systems global head – quality Haresh Amre noted ISO 13485:2003 certification reinforces the company’s commitment to deliver added value in a systematic and predictable manner to its customers in the medical device software market.
"This certification sets the stage for Persistent Systems to expand its Medical Device Software and related service offerings," Amre added.
Persistent Systems Life Sciences & Healthcare senior vice-president Peter Boler noted the company has made a significant investment in the quality systems required to develop and manufacture medical devices, and ISO 13485:2003 represents one of these key investments.
"Obtaining certifications like this allows us to better understand the challenges our customers face and provide them with innovative solutions that are in full compliance with their requirements and those of global regulators," Boler added.
Persistent Systems had obtained other ISO certifications including ISO 9001:2008: quality management system; ISO 27001:2005; information security management system, ISO 14001:2004; environment management system and OHSAS 18001:2007; occupational health and safety management system.