Ritam Priya
Founder & Principal, Novarum MDRQ Consulting
Digital health is transforming everything from chronic disease management to clinical decision support — and the regulatory landscape is evolving just as fast.
About
RITAM PRIYA, MBA, is a quality and regulatory affairs leader with two decades of experience in global medical devices and digital health. She specializes in bridging regulatory requirements with business strategy to drive innovation and compliance. Her work spans emerging technologies such as AI/ML and involves leading diverse, global teams across different time zones to achieve regulatory excellence.
She specializes in the following areas:
- Regulatory pathway & strategy development for medical devices and digital health.
- Regulatory submissions for medical devices, SaMD, and AI/ML-based health software.
- Clinical decision support systems: ensuring regulatory compliance.
- Establishing and managing QA/QMS.
- New product development: from concept through regulatory approval.
- Risk analysis and mitigation to safeguard products.
- Developing clinical strategy to support regulatory and reimbursement goals.
She volunteers with several organizations including the Regulatory Affairs Professionals Society, ASQ World Headquarters, and the Healthcare Businesswomen’s Association.
