Arxan Technologies, a trusted provider of application protection solutions, has announced that BSI Group American Inc. has certified the company to the latest ISO 13485 Certification, the global standard for medical device quality management systems (QMS).
The updated certification is assurance that Arxan meets all of the major global medical device quality system regulatory requirements and demonstrates Arxan’s continued commitment to quality through established and consistent policies, practices and procedures for its entire product suite.
The ISO 13485: 2016 certification replaces the previous version from 2003 and requires detailed compliance with key areas in the lifecycle of a medical device such as protecting confidential health information, obligations around regulatory requirements and a risk-based approach to controls of the quality management system.
The new certification requires complete compliance in regard to process changes, application validation, supporting infrastructure, communications with regulatory authorities and record verification.
“We remain strongly committed to providing the highest levels of quality protection for all connected medical device applications. As the only application security solution to receive this certification, Arxan is in a unique position to protect these critical applications and their users. We’ll continue to expand our certifications, as needed, so that our customers and their patients can be confident in the safety of their life saving devices,” said Joe Sander, CEO of Arxan.
To remain certified against the most recent ISO 13485 compliant requirements, Arxan Technologies underwent a thorough evaluation process that included quality management system (QMS) development, a quality management system documentation review and rigorous assessments for effectiveness of Arxan’s quality management system.
Arxan’s patented technology provides a multi-layered approach to app protection that defends applications that connect to medical devices against attacks, tampering, reverse-engineering and IP theft. The company provides enterprise customer success programs, operates an advanced threat team who monitor for potential customer attacks and provide emergency response if needed, and analytics and threat intelligence for monitoring app security.
ISO 13485 is an internationally recognised quality management system standard for medical devices developed by the International Organisation for Standardisation (ISO). The standard represents an international consensus on good management practices, policies and procedures with the aim of ensuring that organisations can consistently deliver products or services that meet the customer’s quality requirements and all regulatory requirements globally.