Penny Rassmusen, MS
Senior FDA regulatory and device strategy expert with 30+ years of experience guiding medical device companies through 510(k) regulatory submissions, quality system implementation, and compliance in highly regulated environments.
Penny Rassmusen brings deep expertise in regulatory affairs, quality systems, and operational compliance across medical device development and commercialization. She has supported organizations ranging from early-stage innovators to global manufacturers, advising on regulatory pathway strategy, submission development, audit readiness, and cross-functional coordination required to operate effectively within FDA and international regulatory frameworks.
Areas of Focus / Expertise
- Premarket submissions including 510(k) preparation and strategy
- Investigational Device Exemption (IDE) study support
- Quality systems development and implementation (FDA QSR and ISO 13485)
- Internal and external quality audits and compliance programs
- FDA inspection readiness and audit response preparation
- Medical Device Reporting (MDR) and recall management
- Cross-functional coordination across manufacturing, regulatory, and commercial teams
Selected Experience & Impact
Over the course of her career, Penny has authored numerous 510(k) submissions, supported IDE-related studies, and implemented quality systems for medical device organizations operating under FDA and international regulatory frameworks. She has conducted internal and external audits, prepared documentation supporting FDA inspection responses, and helped organizations manage MDR reporting and recall processes while maintaining operational continuity.
Background & Credentials
Prior to FDA Partners, Penny held regulatory, quality, and operational roles supporting medical device companies across manufacturing, quality assurance, regulatory affairs, marketing, and medical education functions in global business environments. She holds a Master’s degree in Global Marketing from Regis University and is a licensed Paralegal. Her professional certifications include ASQC Certified Engineer and Certified FDA/ISO 13485 Auditor, and she holds clinical training as an Advanced Emergency Medical Technician.
Penny brings a practical, operations-focused perspective to regulatory and quality programs, helping organizations build durable compliance systems while maintaining efficiency across complex, multidisciplinary teams.