Software in a Medical Device (SIMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

RAQA Café

A podcast series that tackles trending Regulatory Affairs and Quality Affairs (RAQA) topics within the MedTech industry.

What are the differences between Software in a Medical Device (SIMD) and Software as a Medical Device (SaMD)? In this third episode of NAMSA’s RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Monica R. Montanez (Principal Product Development Strategist) and Lezlie Hynes (Principal Quality Consultant).

During the discussion, they delve into the differences between SIMD and SaMD, as well as FDA criteria deemed essential during the evaluation of the safety and effectiveness of device software with one or more device functions.

Discussion topics include:

What criteria are utilized to classify a device as either SIMD or SaMD?
Are certain regulatory agencies taking the lead on future regulations?
How can we better understand digital health trends?

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Monica R. Montanez

Monica R. Montanez, MS, RAC, CQA currently serves as NAMSA's Principal Strategy Consultant. Monica has over twenty years’ experience 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. She has broad regulatory expertise in several areas of digital health, including: Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), mobile medical apps, clinical decision support software, telehealth, artificial intelligence, machine learning, interoperability, cybersecurity and human factors engineering, including wireless medical devices -radio frequency (RF), electromagnetic compatibility (EMC) and electromagnetic interference (EMI). 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).

Lezlie Hynes

Lezlie Hynes, MT (ASCP), CQA, CSQE currently serves as a Principal Quality Systems Consultant at NAMSA. Lezlie has over 30 years’ experience in the fields of medical device, HCT/P and hospital and reference laboratory industries, primarily in Quality Systems. Her focus is working with Clients—ranging from small start-up to large companies—to develop and maintain quality systems and move products to market. A special focus has been working with Clients to implement and validate computerized systems and assist in product development for SaMD and SiMD products.

Richard M. Granquist

In 2014, Rich joined NAMSA as a Quality Systems Consultant and has now been with the company for eight years. Over his 16 years in the industry, he has participated in numerous AAMI ISO standards committees and currently sits on the committees for ISO 14971, ISO 13485 and ISO 15223. Rich’s medical device industry experience also includes extensive time working with both start-up manufacturers and larger, global device manufacturers. He specializes in quality system development and risk management. Rich started in the medical device industry as a Microbiologist focusing on aseptic technique and terminal sterilization at Cook Medical. During his 8-year career at Cook, he expanded his responsibilities to include coordination of preclinical testing, packaging validation, biocompatibility testing and reprocessing instruction validation for urology and women’s health devices.

Linford Leitch

In 2021, Linford joined NAMSA as a Regulatory Consultant. He has 9 years of experience in the medical device industry with direct regulatory experience with Spine, Transcatheter Heart Valves and Hemodialysis devices. He specializes in developing global regulatory strategies for entry to market and maintain strategies throughout product lifecycle.