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 during development and after initial product launch
Cybersecurity and documentation required by FDA
Understanding which compliance documentation is required when there is no hardware
To help product teams developing SaMD, I’ve created a “map” of SaMD documentation and provided the links below to useful resources on the subject.
SaMD Documentation Map – this downloadable graphic shows the typical documentation needed for an SaMD product and the interdependencies of the documents; it also shows which ones are required for an FDA 510(k) submission.
Essential SaMD Regulatory Documents: Curated List – an extensive list compiled by Orthogonal Software of medical device standards, tutorials, and guidance documents which are ranked in importance (high-medium-low) so you know which ones to study first.
Short course on SaMD, IEC 62304 and IEC 82304-1 – a video tutorial on SaMD with a clear description of the requirements of two key medical software standards by the very knowledgeable Christian Kaestner; published by MedicalDeviceHQ (2023) – 29 minutes.
Cybersecurity
For anyone struggling with documentation for medical device cybersecurity compliance, here’s an excellent guide recently published by Medcrypt and Johner Institut GmbH. “Navigating Cybersecurity Compliance: A Lifecycle Approach for Medical Device Manufacturers” provides an overview and a detailed checklist of what’s needed for FDA and EU compliance. You can download the white paper for free here: https://www.medcrypt.com/whitepapers
Medical Device SBOMs: Best Practices, FAQs, and Examples – a good, practical article describing the basics of creating and managing SBOMs – by Innolitics
Re-Entrant Design Controls
Recorded webinar of my presentation to the Voler Systems’ Group – July 2024
For many software-intensive, connected medical devices, product development does not stop at initial product launch. In this recorded webinar I describe better ways to manage post-market changes and utilize re-entrant design controls: “Embracing Change: Managing Medical Devices that are Never Finished” (from the Voler Systems website).