Workshop on Regulatory, Clinical Pathways on Medical Devices and Healthcare Innovations

KIIT-TBI, with the support of MeitY Startup Hub and in collaboration with AIIMS Bhubaneswar, invites healthcare innovators to a comprehensive two-day workshop. The session is designed to provide an overview of India's healthcare regulatory landscape, offer guidance on clinical validation, quality norms, and certifications, and enable expert-led discussions on regulatory challenges for startups.

Key Insights:

• India's evolving regulatory landscape: Medical device, diagnostics & drugs.
• QMS and ISO 13485: 2016 Implementation.
• EU MDR / IVDR & FDA 510(k) pathway.
• Risk Management, Post-Market Surveillance, and product recall readiness.
• Ethical and Clinical Validation Pathways.
• Documentation, GMP, and audit preparation.

Expected Outcomes:

• Improved understanding of regulatory processes among clinician innovators and startups.
• Early-stage regulatory readiness & documentation templates for participating teams.
• Identification of startups for advanced mentoring under KIIT-TBI's MSH support.
• Leveraging the strengthened AIIMS–KIIT-TBI collaborative ecosystem.

Participation:

• Clinician Innovators & Researchers from AIIMS and affiliated hospitals.
• Healthcare Startups (MedTech, Biotech, Digital Health, Diagnostics).