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Article

Agile in an FDA Regulated Environment

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How do you get the benefits of agile while maintaining quality and regulatory compliance?

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Article

Orthogonal Obtains Medical ISO 13485 Certification

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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 […]

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Article

Applying Agile in a Quality Management System

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Orthogonal CEO Bernhard Kappe, reviews the use of Agile development principles under a Quality Management System pursuant to FDA guidelines and regulations.

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Article

Connected Health Conference for Med Device Companies

agile, digital health, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Mobile apps and connected technologies are changing the way that medical information and services are acquired, processed, conveyed, and implemented. New products, emerging not only from the traditional medical device industry, but from the consumer […]

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Article

10 Myths About Agile and the FDA

agile, FDA, medical device software development

Myth: Verification and Validation should only start after all development is complete.  Truth:  In traditional waterfall, verification and validation activities often commence at the tail end of a project, after all, development is complete.  This diverges from the FDA’s recommendations: “The FDA does recommend that software validation and verification activities be conducted throughout the entire […]

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Article

Agile Without Fast Feedback is Not Agile

agile, FDA, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Agile methodology has been adapted to the medical device industry to incorporate risk management, human factors and verification and validation so that it satisfies both the letter and the spirit of the FDA’s Quality System […]

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