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 […]
Newsletter V. 2024 Issue 3 Read More »
Last modified: 18-NOV-2024 Software as a Medical Device (SaMD) products do not involve hardware or manufacturing but their documentation is still complicated and it can be difficult to know what is truly required for compliance. To help reduce the confusion, I created this SaMD Documentation Map which illustrates the formal documentation needed for a typical
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“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,
Embracing Change: Managing Medical Devices That Are Never Finished Read More »
Embracing Change: Managing Medical Devices That Are Never Finished Online webinar – July 25 Join us for a lively discussion by Aaron Joseph of how to tackle the challenges of managing software-intensive, connected medical devices; products that we want to grow and evolve after initial launch. Bring your questions on how to set up a
Newsletter V. 2024 Issue 2 Read More »
March 2024 – What are “re-entrant design controls” and why would a medical device company need them?
Newsletter V. 2024 Issue 1 – Embracing Change for Medical Device Excellence Read More »
