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SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies



April 21, 2021

One of the most relevant and talked about topics in the medtech industry in recent years is related to Software as a Medical Device (SaMD), and these devices present particular challenges as technology advancements often outpace global regulations and other industry guidance. As a result, device Sponsors are required to have earlier and more frequent interactions with regulatory agencies in an effort to align on regulatory pathways, clinical data analyses and more.

When factoring this in with additional Quality System requirements and new guidance and/or industry information, Sponsors can begin to feel overwhelmed with nowhere to start. Today’s regulatory affairs professionals must not only have a solid foundation surrounding SaMD regulations, but also an in-depth understanding of how these requirements link to quality and clinical data requirements through the full product development continuum to achieve efficient, cost-effective outcomes.

This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss how early integration of regulatory, quality and clinical data planning are the keys to commercial success.

Upon conclusion of the program, participants will:

  • Understand how to better navigate regulatory requirements and recommendations for SaMD products
  • Know how to build effective Quality Systems that adhere to SaMD requirements through the Total Product Development Lifecycle
  • Learn best practices for discussions with the FDA regarding SaMD products, including key information to present during these interactions
  • Understand SaMD clinical evaluations at a high-level
  • Learn how to handle clinical data and how to position data in support of regulatory submissions
  • Understand how post-launch support surrounding software maintenance, re-validation, decommission and disposal of the Health Software products is helpful
  • Realize how leveraging best practices linking regulatory, quality and clinical data strategies can save costs throughout the development process and accelerate commercialization

To register for this on-demand webinar, please fill out the following form.


Monica R. Montanez, MS, RAC

Principal Regulatory Consultant

Monica has over twenty years in the medical device industry in Regulatory Affairs and Quality Assurance. Her primary focus is navigating the regulatory pathways for electro-mechanical and software driven medical devices worldwide. She has received clearance of many 510(k)s and approval of new indications for PMA device(s) of which 90% involved software. More recently, she has broadened her regulatory experience in the area of digital health that includes: Software as Medical Device (SaMD), Mobile Medical Apps (MMA), Digital Therapeutics (DTx), Artificial Intelligence (AI), Machine Learning (ML), Cybersecurity, Usability, and Risk Management. While in industry, she assisted in the development of FDA 510(k) guidance and FDA Software guidance directly with FDA.

Monica holds a Masters of Science (MS) degree in Regulatory Science (RS) from the University of Southern California (USC) School of Pharmacy. Currently, she holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).

Chris Mullin

Chris Mullin, MS, RAC

Director, Product Development Strategist

Chris Mullin is currently the Director, Product Development Strategy at NAMSA where he oversees and manages client partnerships surrounding product development, regulatory, clinical, and market commercialization strategies. Chris began his career working on National Institute of Health (NIH)-funded academic clinical trials, and over the last 15 years, he has consulted for medical device organizations throughout the U.S. Asia, and Europe on various clinical trial programs. A highly sought-after industry expert, Chris has helped more than 100 global manufacturers optimize study design and research, providing proven strategies to address regulatory requirements for market approval and introduction. Chris has worked with multiple innovative technologies across a wide array of therapeutic areas, which has allowed him to provide valuable perspectives to clients on scientific and regulatory challenges – and suggested strategies for success – that impact the advancement of novel medical technology. Chris is a renowned leader in FDA Panel reviews and an extensive author; he has authored multiple peer-reviewed publications as well as a book chapter on clinical study design for translational research, has served as a lecturer for multiple universities, and serves as a journal editor. Chris holds a Master’s Degree in Biostatistics from the University of Minnesota.