Wherever you are in your product development lifecycle,
Sterling can help.
Author: Dharma Kallur | Date: October 11, 2023
Navigating the complex world of regulatory affairs for medical device software design can feel like trying to find your way out of a complex spider web. Each strand represents a different guideline, standard, or requirement that intertwines with another, demanding meticulous attention to detail. As you move through the process of designing and developing your medical device software, changes may arise—whether from technology updates, feedback loops, or even unforeseen challenges. The process you have in place to manage those changes directly impacts the integrity, functionality, and compliance of the software. Without an adequate change control process, your medical device software may become vulnerable to regulatory penalties, software malfunctions, or compromised patient safety.
Per the FDA 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016, an effective change control process is crucial in medical device software development. One of the most effective ways to ensure consistent adherence to these standards and maintain product integrity is to implement a structured Software Development Life Cycle (SDLC) model, following an agile methodology. This approach allows you to systematically document, rigorously validate at each phase, and continuously gather feedback. By breaking the development process down into smaller, more manageable steps to support ongoing modifications, upgrades, and iterations, you can ensure that the software remains adaptive and resilient.
Here are some additional considerations to keep in mind:
Navigating changes during the software design and development process for your medical device involves more than understanding and applying applicable regulatory standards; to ensure seamless integration, regulatory compliance, and maintain product integrity, you need to establish a robust change management system that is fluid, comprehensively addressing each phase of the software lifecycle while embedding a proactive approach to risk management.
Not sure where to start in implementing a change control process for your medical device software? Sterling can help. We know all there is to know about software design for medical devices and the comprehensive requirements mandated by dozens of regulatory bodies worldwide. By working with a partner who is well versed in regulatory affairs, your medical device software design and development process—and the changes that occur along the way—will be met with success.
We’ll help you create a change control process for your medical device software that maintains adherence to the strict regulatory regulations, keeps your project on track, and gets you to market quicker. Contact us here to learn more.
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