Monica Ferrante

Monica Ferrante is a Regulatory and Quality executive who has worked for and consulted with medical device companies across a broad spectrum of products with both start-ups and large multi-national corporations.  The first 10 years of her career involved software development for nuclear power plant simulators and systems communication testing of satellites.  For the past 30+ years she has worked in medical device regulation initially as a scientific reviewer for the FDA. She has experience with regulatory processes related to development, submission, market clearance and post approval requirements for devices such as surgical lasers, multi-parameter patient monitors, defibrillators, ultrasound devices, ventilator and resuscitation devices, neonatal incubators and radiant warmers.  In addition to capital equipment, she has experience with sterile and non-sterile disposable and consumable devices and accessories.  She has also supported several Clinical Studies with regards to regulatory requirements, clinical trial database registrations, and FDA Investigations of clinical sites, adverse event review and study documentation. Submission experience extends from documentation of exempt devices, numerous 510(k) submissions, Investigational Device Exemptions, Premarket Approvals, Supplements, Periodic Reports and Reclassification petitions.

Monica has developed and maintained Quality Systems which met the requirements of FDA Investigators and ISO Auditors as evidenced by successful FDA Inspections with no or few 483 findings and Quality System Certifications in support of several international regulatory requirements such as ISO 13485, MDSAP, GOST and ANVISA. She has also successfully worked with the FDA to address Warning Letters which then resulted in re-commercialization of products suspended from marketing by FDA, and re-established the integrity of the company with regulators.  Monica has executed regulatory submissions and achieved approvals worldwide to include Europe, pre and post Medical Device Directive, Canada, Mexico, Cuba, Japan, Brazil, South Africa, Russia, Eastern Europe, China, Korea and the Middle East. 

Monica has participated on AAMI Technical Standards committees, presented at conferences and taught multiple seminars on medical device regulation.  Education includes a BS in Biomedical Engineering from Catholic University, MS in Physiology from Georgetown, MPA and DPA in Public Policy from USC. She has one Patent issued, and one pending.