I believe that regulatory requirements shouldn’t be a barrier to innovation. They
should be the framework that ensures your medical advancements reach the world safely and efficiently.
As the lead strategist and the founder of Tanya Shalem LLC, I bring over 18 years of experience
guiding companies through FDA submissions, EU MDR transitions, QMS implementations, and global
regulatory requirements. My expertise centers on complex multidisciplinary devices, specifically
diagnostic imaging that integrates hardware, software, and deep learning algorithms.
With a B.Sc. in Quality Engineering and a Master of Engineering in Industrial Engineering and
Management from the Technion – Israel Institute of Technology, I work closely with technical teams to
translate complex business and regulatory objectives into practical engineering steps, keeping your
project moving toward its milestones.
Based in the San Francisco Bay Area, my team and I help medical device and life science companies to
bring new technologies to market, build strong and efficient processes, and guide suppliers and
internal teams while maintaining a high level of regulatory compliance.
Tanya Shalem
CEO and Head of Quality & Regulatory Affairs
Our Mission
To guide medical device and life science organizations through complex quality and regulatory requirements with clarity, integrity, and precision enabling the development and commercialization of safe, effective, and compliant technologies.
Our Approach
Clear and Actionable
We translate complex regulations into structured, manageable steps. By providing the technical clarity your team needs, we ensure you can make informed decisions and maintain steady progress toward market access.
Collaborative and Committed
We act as a seamless extension of your organization. Grounded in 18 years of technical and executive experience, we don’t just consult; we take ownership of your most critical quality and regulatory milestones.
Integrated and Scalable
We provide a unified Quality and Regulatory suite tailored to your company’s specific size and stage. By aligning global strategy with your business goals, we build flexible systems that support your innovation and grow with you.