Navigating SaMD and SiMD: Real-World FDA Regulatory Strategies for Medical Device Software

Medical Device, Medical Device Safety and Regulation,
  • Wednesday, December 06, 2023

Discover a groundbreaking webinar delving into how to navigate The Food and Drug Administration (FDA) regulations for healthcare software products, and explore regulatory strategies, pathways to market and clinical data expectations. Software products are used in a variety of healthcare applications including tracking personal health and well-being, monitoring vital signs, administering therapies, facilitating diagnoses and treatment decisions and aiding with surgical procedures.

This webinar will discuss how to determine whether a software function and/or product meets the definition of a medical device, software as a medical device (SaMD) or software in a medical device (SiMD), that is subject to The FDA regulatory oversight. Potential pathways for bringing these software products to market will be explored along with points to consider in developing short and long-term regulatory strategies. The expert speaker will also discuss how algorithm training and validation and clinical data expectations may be impacted by the selected regulatory pathway.

Join this webinar and dive into The FDA regulations for healthcare software products, covering strategy, pathways and clinical data expectations.


Connie Qiu, MEng, RAC, Senior Consultant, Regulatory Affairs, ProPharma MedTech

Connie Qiu is a regulatory affairs professional with more than 10 years of experience providing regulatory and quality system support to the medical device industry. She has prepared and managed multiple regulatory projects that support FDA pre-submission meeting packages as well as 510(k), De Novo, PMA and PMA supplement submissions.

Ms. Qiu is a subject matter expert for software-based devices and interoperable medical devices containing a software component, including SaMDs leveraging machine learning and artificial intelligence. She is knowledgeable in the development of sound regulatory strategies for all classes of medical devices, including preparation of testing requirements, software risk assessment, electrical safety and human factors testing. Ms. Qiu also supports clients in preparing software documentation for their design history files.

Ms. Qiu has developed regulatory strategies for innovative technologies from monitoring devices to diagnostics, as well as wellness products.

Message Presenter

Who Should Attend?

This webinar will appeal to professionals in the following industries:

  • Regulatory affairs
  • Clinical development and operations
  • Clinical trials
  • Project management
  • Research and development
  • MedTech C-suite

What You Will Learn

Attendees will gain insights into:

  • Developing regulatory strategies for medical devices with software components
  • Comparison of US regulatory landscapes and pathways to market
  • Clinical data expectations, algorithm validation and training
  • Considerations for developing regulated software medical device products
  • Real-world examples of applied strategies

Xtalks Partner


For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account