Articles

Thought Leadership on SaMD, DTx & Connected Device Systems

MedTech is accelerating to Internet Speed. Join the 5000+ readers who keep pace with our monthly newsletter.

  • MM slash DD slash YYYY

Article

Agile in an FDA Regulated Environment

agile, FDA

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

Read More

Article

Orthogonal Obtains Medical ISO 13485 Certification

agile

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 […]

Read More

Article

Applying Agile in a Quality Management System

agile

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

Read More

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 […]

Read More

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 […]

Read More

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 […]

Read More

Article

Medical Software Under UX Influenced Development

agile, FDA, Human Factors & UX, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Clayton Miller is a user experience (UX) and visual designer at Orthogonal. His previous agency experience in the visual design world ranges from basic design work to UX design and development. Since joining Orthogonal, Miller […]

Read More

Article

Faster Feedback Before Development Starts: Feasibility

agile, FDA, lean startup, medical device software development

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. While change, new discovery and learning are inevitable during any healthcare app product development process, and agile processes reduce the cost and risk of change, there is a significant cost associated with design controls for […]

Read More

Article

Faster Feedback Through Integrated Cross-Functional Teams

agile, FDA, Human Factors & UX, medical device software development, risk management, verification & validation

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. In FDA regulated software development one of the most important keys to getting the most out of agile methodology is to ensure fast feedback from outside of the development team. One way to do this […]

Read More

Article

Getting Your 510K Medical Software Ready

agile, FDA

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Medical devices have become so indispensable to modern healthcare that practically no major diagnosis or treatment can be done without them. According to the WHO, an estimated 1.5 million medical devices are currently available, ranging from […]

Read More

Article

User Experience in an FDA Environment

agile, FDA, Human Factors & UX

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. Navigating UX through an FDA Environment Amy Willis brings years of field experience to her current role as Director of User Experience and Visual Design at Orthogonal. As part of her responsibilities in this position, […]

Read More
1 2 … 5
BSI ISO 13485 Logo
Terms of Use | Privacy Policy | Careers
All Rights Reserved © 2024 Orthogonal