The international standard IEC – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the. Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common . IEC specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates .
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Orthogonal, the leader in companion software development for medical devices, today announced it has been successfully certified according to ISO All you need 62304 read in the other general jounals BMJ ; Click here to Renew Now. Citing articles are presented as examples only. Sign in or create your free personal ASME account. 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.
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IEC – Wikipedia
Orthogonal applies agile practices, test automation and user experience design within an IEC and IOS compliant quality management system to build FDA cleared and CE marked systems for patient adherence, continuous monitoring, early detection and prevention, personalized iex and chronic condition management. Daniel Stiffler and Stephen Seaman.
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ISO is based on quality management principles that have been proven to enhance organization performance. Customize your page view by dragging and repositioning the boxes below. Some tools below are only available to our subscribers or users with an online account.
Sign into or create your free personal account. You either do not have a subscription or your subscription has expired. Learn about subscription and purchase options. About Orthogonal Orthogonal is a company specializing in connected medical devices and mobile and cloud companion software.
Orthogonal Obtains ISO 13485 Certification for Medical Device Software
If your institution uses Shibboleth authentication, please contact your site administrator to receive your user name and password. Stiffler C, Seaman S. Obtaining ISO 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.
IEC – Medical device software — Software life cycle processes
Orthogonal is a company specializing in connected medical devices and mobile and cloud companion software. Check Out Now Continue Browsing.
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These principals relate to customer focus, management, internal processes and external relationships.