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Monica R. Montañez, MS, RAC, CQA

Product Development Strategist, Regulatory

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Monica Montañez has over 20 years of experience in the medical device industry, working with a broad range of medical device technologies and organizations.

Prior to joining NAMSA, Monica worked at several different medical device organizations, including Millar Instruments, Cyberonics, CONMED, Generic Medical Devices, Inc, Cochlear and Medtronic. Currently, Monica works in consulting, focusing on manufacturers with complex submissions for novel devices. She is NAMSA’s in-house expert for regulatory software as a medical device and artificial Intelligence, machine learning. Monica holds a Master of Science in Regulatory Science from the University of Southern California (USC) School of Pharmacy.  

CORE COMPETENCIES 

  • Authored regulatory strategy/plans for new and next generation implantable cardiovascular, orthopedic, ENT, neuro- stimulation, image guidance navigation, general surgery, peripheral devices and organ perfusion, including monitoring/programming, Software as a Medical Device (SaMD), wearables, sensors, Internet of Things (IoT) and artificial intelligence/machine learning.
  • Authored multiple submissions to the U.S. Food and Drug Administration (FDA), including traditional and special 510(k)s, pre-submissions, IDEs and PMAs, as well as their associated reports, amendments and supplements.
  • Authored multiple pre-submissions with FDA, including pre-IDE, Informational, PMA-100 day meetings, pre-510(k), De Novo, interactive reviews and strategic development meetings (ex. PMA panel meetings).
  • Subject Matter Expert: loT and the EU Radio Equipment Directive (RED) 2014/53/EU, Federal Communications Commission (FCC) and worldwide telecommunication submission expert (interactions/advocacy).
  • Subject Matter Expert: Digital Health-Software in a Medical Device (SiMD), 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).
  • Assisted in the integration of the risk management process and its implementation according to ISO 14971. Key team member for the integration of the risk management process for cybersecurity assessments of the impact of threats, vulnerabilities on device functionality and end user/patients.
  • Technical leadership on design/software verification and validation studies, establishing compliance to the device specific standards (ISO/IEC/ASTM), quality standards and internal processes and procedures.
  • Developed SOPs/templates and provided in-person training and training via webinars for Software Development Lifecycle (SDLC) requirements per ISO 62304 and ISO 82304 for SaMD: Good Machine Learning Practices (GMLP).

RECENT PROJECTS 

  • Provided software and hazard analysis support, including cybersecurity threat analysis for a De Novo Request that introduced a software-only digital therapeutic device used with commercially available Head-Mounted Displays (HMDs). This De Novo was approved by FDA in 2021. 
  • Recently obtained FDA PMA approval for a Liver Machine Perfusion system and a breakthrough device designation request for a Heart Machine Perfusion system. 
  • Established SDLC SOPs and templates according to ISO 62304, ISO 82304 and FDA Guidance: Guidance for the Content of Premarket Submissions for Software, including consideration for new “draft’ for several clients. Supplemented with GMLP to include Data Management and Model Development.