
Your Partner for Agile QMS, Regulatory Clarity & Speed to Market
We combine deep MedTech experience with strategic, forward-thinking leadership to help organizations build scalable, compliant quality systems that align speed, innovation, and compliance across the product lifecycle. From FDA and global regulatory navigation to QMS optimization and audit readiness, we serve as a trusted thought partner from early development through commercialization. We empower teams, streamline processes, and help companies deliver innovative, high-quality medical devices that improve patient outcomes.
About the Founder
Jennifer Mascioli-Tudor is an experienced leader, who brings more than 20 years of industry experience in Quality and Regulatory leading global teams within the pharmaceutical and medical device industries. She has an extensive background in leadership and global quality assurance, regulatory affairs, and operational excellence.
Jennifer has progressed through several roles of increasing leadership responsibility working for companies such as Johnson and Johnson, Medtronic, Nevro, American Medical Systems, Boston Scientific, Outset Medical and GE Healthcare. She is passionate about building energized, diverse and inclusive teams and driving efforts around process optimization and continuous improvement.
She started JMT Compliance Consulting to work with organizations to drive Quality, Regulatory and Organizational excellence across the medical device and other complimentary industries.
She holds a B.S. in Physiology/Chemistry and French from Eastern Michigan University and an M.B.A. from the University of Phoenix. She was born and raised in a small Northern Ontario town in Canada and now lives in Mountain View, California with her husband and two kids.

Education & Certifications

International Association of Professions Career College
Executive Coach Certification

Management and Strategy Institute
Six Sigma Black Belt Professional Certification

University of Phoenix
MBA, Emphasis in Global Management

Eastern Michigan University
B.Sc., Physiology/Chemistry/French (fluent in both writing and speaking)
Professional Memberships & Associations

UC San Diego
Instructor, Overview of Regulatory Affairs for Medical Devices & Design Control for Medical Devices

American Society for Quality (ASQ)
Member

Regulatory Affairs Professional Society (RAPS)
Member
Our Partners

Greg Matson
Quality Specialist

Matt Mignogna
Change Management

Naz Moeini
Regulatory

Bryan Mascioli
Operations
How We Work
Discovery & Assessment
We begin by understanding your current state, challenges, and compliance objectives through comprehensive system reviews and stakeholder interviews.
Strategic Planning
We develop tailored solutions and roadmaps that align with your business goals, regulatory requirements, and operational capabilities.
Implementation & Execution
Our team works alongside yours to implement quality systems, develop documentation, and execute remediation activities with minimal disruption.
Knowledge Transfer & Sustainability
We ensure your team has the tools, training, and confidence to maintain compliant systems long after our engagement ends.
