Orthogonal, the leader in companion software development for medical devices, today announced it has been successfully certified according to ISO13485:2003, the international standard for medical device quality management systems. The certification bestows official recognition on the company for its agile enabled quality management system governing software product design, development, testing, enhancement and support for medical device software.
Orthogonal was awarded certification by BSI, one of the world’s leading certification bodies/registrars offering the latest in management systems certification services.
“Today’s medtech environment presents new challenges and opportunities for medtech innovators,” said Bernhard Kappe, CEO of Orthogonal. “Sensors, connectivity, smartphones and cloud computing are evolving at ever increasing speed, and the FDA, payers and providers are demanding more and more real-world evidence to support value-based care. We’ve built and battle-tested our processes to specifically address these challenges, by integrating user experience design, agile methods and testing automation to deliver quality at speed. Obtaining ISO 13485 certification further confirms that we can provide our customers with innovative solutions that are in full compliance with their requirements and those of the FDA and global regulators.”
About ISO 13485:2003:
ISO 13485: 2003 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principals relate to customer focus, management, internal processes and external relationships.
Orthogonal is a company specializing in connected medical devices and mobile and cloud companion software. Based in Chicago and San Francisco, Orthogonal develops Class I, II and III software as a medical device (SAMD) systems in a broad range of areas, including cardiology, diabetes care, neuromodulation, drug delivery and orthopedics. Orthogonal applies agile practices, test automation and user experience design within an IEC 62340 and IOS 13485 compliant quality management system to build FDA cleared and CE marked systems for patient adherence, continuous monitoring, early detection and prevention, personalized therapies and chronic condition management.