Rules Are Changing for FDA Submissions for Software
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
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Newsletter V. 2021 Issue 2
September 2021 Newsletter – Digital Health and Medical Device Software Digital Health encompasses a broad range of products leveraging the latest software and communication technologies to improve patient health and increase the efficiency of healthcare systems. Some of the most innovative are software-only products (SaMD) utilizing sophisticated algorithms to analyze health data and aid clinicians
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Documentation for Medical Device Software
The documentation needed for medical device software is lengthy and complex. This article provides a list of needed documentation and tips on the best way to manage it.
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Accelerating Value Delivery for Medical Device Software
Erik Heuer describes his experiences accelerating medical device software development by bridging the gap between regulatory compliance and modern software development methods: incorporating DevOps concepts, leveraging documentation automation, and establishing the two wheels for innovation vs. development and deployment.
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Post-Mortem Pre-Celebration
A post-mortem or retrospective is a valuable opportunity to make long-term improvements in a product development organization. Understanding the goals of a post-mortem and avoiding the 4 common pitfalls will ensure a successful and valuable outcome of the post-mortem.
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Successful Product Development: A Tale of Two Companies
Product teams that skip Phase Zero and jump straight into development appear to be on a faster path to market. But the consequences of a lack of Phase Zero will become painfully apparent late in product development, when problems are much more expensive to fix.
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Intro to SaMD
SaMD, or Software as a Medical Device, is not just another mobile app. It is a new category of medical device that has particular regulatory considerations and is at the forefront of some of the most innovative new healthcare technology.
Newsletter V. 2021 Issue 1
April 2021 Newsletter – Better Approach to Medical Device Development Let’s Get Back to Basics Medical device development is often discussed in terms of adhering to new regulations or standards. While the complexities of good compliance are certainly important, it’s easy for teams to overlook the basics of what’s needed to successfully develop an innovative
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Micro Projects and Other Practices
Proven ideas to be able to catch problems earlier in complex product development, rather than wait for the finale of a big integration. Break the large stretches of work into small micro projects. When possible, build prototypes in these micro projects and demonstrate to customers to get early feedback.
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Forming the Right Product Development Team
The right product development team is much greater than the sum of its individual team members. Forming teams for complex product development involves effective leadership, cross-functional contributions and optimized team structure for the project.
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