Webinar: Navigating SaMD and SiMD 

Real-World FDA Regulatory Strategies for Medical Device Software

In this webinar, we explore the intricacies of FDA regulations for healthcare software products. Our expert speaker shares insights on navigating the FDA landscape, understanding regulatory strategies, pathways to market, and clinical data expectations. You will gain a comprehensive understanding of software functions and products within the medical device realm, whether categorized as medical devices, software as medical devices (SaMD), or software in medical devices (SiMD), all falling under FDA regulatory oversight.

We'll delve into potential pathways for bringing these software products to market and discover crucial elements for developing effective short and long-term regulatory strategies. Our expert speaker will illuminate the impact of selected regulatory pathways on algorithm training, validation, and meeting clinical data expectations.

Watch now to gain valuable insights into FDA regulations governing healthcare software products, covering strategy, pathways, and clinical data expectations.

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Meet the Speaker

  • Connie Qiu Bio Photo

    Connie Qiu

    Senior Consultant, Regulatory Affairs, ProPharma MedTech

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Connie Qiu

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 which 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 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.  

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