Requirements have been met for the development, production, distribution, installation and servicing of BoneMRI.
Utrecht, May 18, 2022 – MRIguidance has achieved the International Organization for Standardization (ISO) 27001:2017 certification for the information security management system, on April 22, 2022.
ISO 27001 is a global benchmark standard for information security that takes a systematic approach to ensuring the confidentiality, integrity and availability of sensitive company and customer information. The certificate encompasses the information security of the design and development, production, distribution, installation and servicing of medical imaging processing software BoneMRI, both on premise and in cloud applications, for the area of radiology.
Brand Compliance, an independent, third-party auditor accredited by the Dutch Accreditation Council (RvA) to perform ISMS 27001 certifications, has certified that MRIguidance has the proper technical controls and formalised IT security policies and procedures in place to ensure safeguarding sensitive company and customer data.
“MRIguidance is committed to meet or exceed our customers’ expectations. We understand that managing information security is a prerequisite to meet these expectations,” says Marijn van Stralen, CTO of MRIguidance. “Achieving the most widely recognised information security certification is not only an industry differentiator, but also a significant accomplishment and testament to our ongoing commitment to delivering high quality.”
This certification expands the list of previously obtained regulatory achievements which include: ISO 13485 (Quality Management System for Medical Devices) certification; MDR CE certification; FDA clearance, together with GDPR compliance.