FDA Digital Health Regulation: Latest Developments for Medical Device Manufacturers – Webinar Recording/Transcript
With the expansion of the digital health space, the number of products classified by the FDA as Software as a Medical Device (SaMD) is growing. And while the FDA has long regulated medical device hardware, the requirements around software are newer — with their own set of unique challenges. If your team is using software on a medical device platform, in an off-the-shelf product or on a virtual network, you need to understand these developing regulations.
Are you prepared to apply these regulations to your software-intensive medical devices? Are you familiar with the digital tools available to increase reproducibility? Are you skilled in using real-world monitoring of software devices to increase your compliance?
After this FDA Digital Health Regulation presentation, you will be.
With this expert advice, you’ll be able to determine the differences between traditional medical device regulations and SaMD regulations. You’ll learn the unique risks that software-intensive medical devices pose to the healthcare ecosystem and figure out how to build regulatory practices directly into your systems development lifecycle. Expert tips will also help you ease any inspection and audit burdens you might face when pushing your SaMD forward.
- SaMD Regulation Details
- The differences between traditional medical device regulations and SaMD regulations
- The unique and novel risks software-intensive medical devices pose to the healthcare system
- Difficulties and benefits that can come from SaMD versus 510(k) compliance
- Ways to ask product managers, engineers and other development professionals for proof of safety and efficacy
- A new RegOps approach that could allow regulatory artifacts to be generated as byproducts of the SaMD development effort
- How automated RegOps could reduce preparation time for FDA submissions
- How building regulatory practices directly into the systems development lifecycle could ease inspection and audit burdens
- Creating more reliable results through directly building in regulatory practices
Don’t let these new and growing regulations get in the way of the success of your software-intensive device.
Meet Your Instructor
Shahid Shah, Cofounder and Chairman of the Board at Citus Health, has more than 30 years of experience in technology strategy, software engineering, entrepreneurship, and speaking and writing on these subjects. He an award-winning expert in health IT, medical device integration software, and Government 2.0. He has built both traditional 510(k) and SaMD solutions, and he has spent years educating the industry about medical device interoperability and regulatory science.
Who Will Benefit
- Teams building software-intensive medical solutions
- Marketing leaders
- Regulatory affairs leaders
- Regulatory compliance professionals
- Product manager
- Quality assurance professionals
- Inspection and audit professionals
- Postmarket safety teams
- Submissions and approvals staff
- Research and development teams
- Commercial operations staff
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April 8, 2021