Aaron Joseph, Author at Sunstone Pilot, Inc.

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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Agile can lead to better medical device development

Secrets to Unlocking Agile Benefits for Medical Device Development

1 Comment / Lean & Agile, Medical Device Development, V2025

Agile medical device development can provide tremendous benefits but agile methods must be modified for successful hardware development and regulatory compliance. The MAHD Framework provides a proven process with these modifications.

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Medical device design controls are a subset of product development processes

Underestimating and Overestimating Design Controls

Leave a Comment / Design Controls, V2025

Medical device design controls are not a separate set of activities run in parallel to product development–they are a central part of development.

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Newsletter V. 2025 Issue 1

Leave a Comment / News, Newsletters, V2025

Topic: Time to rethink developing software-intensive medical devices Understanding medical device software compliance starts with processes Accelerated change management with The Hub Managing product data in a platform (The Hub) enabled the product team to rapidly respond to unexpected design changes at the worst time (in the middle of V&V) while still generating rigorously controlled

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Diagram showing categories and sub-categories of software at a medical device company superimposed on a painting of a landscape

Understanding the Software Landscape

1 Comment / Software Development, Software Tools, V2025

Understanding all of the types of software at a medical device company is crucial to knowing what is required for validating, documenting, and controlling each type

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Activities defined in the IEC 62304 software standard drive the required documentation

Secrets to Medical Device Software Documentation

Leave a Comment / Regulatory Compliance, Software Development, V2025

Here’s a secret about understanding medical device software documentation: don’t start with a checklist of documents! Instead, start by understanding the processes necessary for compliance and the activities in those processes.

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Warm Wishes from Sunstone Pilot

Newsletter V. 2024 Issue 3

Leave a Comment / News, Newsletters, V2024

SaMD SaMD (Software as a Medical Device) products are at the forefront of some of the most innovative new healthcare technology but present particular challenges to medical device companies. Understanding and tackling these challenges will go a long way to making your next SaMD product a success. Some of the key challenges are:Managing frequent changes

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SaMD Documentation Map

Leave a Comment / Regulatory Compliance, Software Development, Software Testing, V&V Testing, V2024

This SaMD Documentation Map illustrates the formal documentation needed for a typical Software as a Medical Device (SaMD) product. The map is a graphical representation of the interdependencies of the product documentation and what is needed for an FDA 510(k) submission.

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Embracing Change: Managing Medical Devices That Are Never Finished

Leave a Comment / Medical Device Development, V2024, Videos

“Embracing Change: Managing Medical Devices That Are Never Finished” was recorded in July 2024 as part of Voler Systems’ webinar series How do we manage upgrades to a new medical device after product launch? If you don’t expect to ever make changes to the product then this may not be a concern at all. However,

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