Aaron Joseph

The Hub is a central platform to generate all the documents

Platform Approach to Managing Development of Medical Devices

Leave a Comment / Software Development, V2025

“Don’t depend on documents to manage your documentation!” Product teams developing a new medical device need to produce a lot of documentation but that doesn’t mean they should use the documents to manage all the product data, especially for software-intensive medical devices.  “Are these the latest software requirements? Who has the latest draft test protocol?” […]

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Rapid Compliance with the IEC 62304 Medical Software Standard

Rapid Compliance with the IEC 62304 Medical Software Standard

Leave a Comment / Case Study, Testimonials, V2025

CLIENT Small Medical Device Manufacturer (<200 employees) Company Stage: Two hardware products launched; working on their first digital health product (SaMD) CHALLENGES Client had no experience with mobile or cloud software; relied 100% on development partner Software development partner had no experience with medical devices and regulations; they were making undocumented and uncontrolled changes to

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