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Monica R. Montañez, MS, RAC, CQA

Principal Strategy Consultant, 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. Some therapeutic areas to highlight: Cardiology, Neurology, Dental, GastroRenal Urology, Ophthalmic, Respiratory, Clinical Decision Support Software, Artificial Intelligence, Machine Learning, In Vitro Diagnostic and General Surgery, among others.

Monica began her medical device career with Millar Instruments and then with Cyberonics (now Liva Nova), CONMED, Generic Medical Devices, Inc, Cochlear and before joining Medtronic in 2010. With NAMSA, Monica then moved into consultancy where the focus of her work has always been working with manufacturers with complex submissions for novel devices. She is the in-house expert for regulatory software as a medical device and artificial Intelligence, machine learning. Monica also holds a Master of Science in Regulatory Science from the University of Southern California School of Pharmacy and a Regulatory Affairs Certification from the Regulatory Affairs Professional Society (RAPS).


  • Specializes in FDA interactions and strategy, development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials and regulatory strategy for medical devices
  • Authored regulatory strategy/plans for new and next-generation implantable cardiovascular pacemakers, defibrillators and wearable heart monitors, dental, orthopedic, ENT, neuro- stimulation, image guidance navigation, in vitro diagnostic (IVD), general surgery, peripheral devices, organ perfusion, including monitoring/programming, Software as a Medical Device (SaMD), wearables, sensor, LoT, 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: Internet of Things (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), Software as a Medical Device (SaMD), mobile medical apps, clinical decision support software, computer aided devices, 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
  • Provide training for Software Development Lifecycle (SDLC) requirements per IEC 62304 and IEC 82304 for SaMD: Good Machine Learning Practices (GMLP), SOPs/Templates: webinars and for client groups
  • Manage projects for SaMDs that include a clinical decision support tool for dental, drug-resistant epilepsy, ECG prediction for AFib/Stroke, radiological image processing and analysis tool of CT scans, DTx devices: asthma, COPD, cognitive; Extended Reality (XR) Therapeutic and Diagnostic Devices: cognitive impairment, as well as Computer-Aided Devices including Triage, Notification, Detection, and Diagnosis (CADt, CADe, CADx and CADe/x)


  • Planned and managed Breakthrough sprint interactions for a novel Class II and Class III device(s)
  • 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
  • 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 IEC 62304, IEC 82304-1 and FDA Guidance: Guidance for the Content of Premarket Submissions for Software, including consideration for new “draft’ for several clients.  Supplemented with Good Machine Learning Practices, to include Data Management, and Model Development