Medical Device Regulatory Standards Internship

Overview:Learn how to navigate global medical regulations like ISO 13485, US FDA 510(k), EU MDR, and BIS certifications, with real documentation and device lifecycle workflows.

Learning Outcomes:

• Draft QMS and regulatory documents.

• Understand design traceability, risk analysis, CAPA.

• Study essential principles checklist and technical files.

• Prepare clinical evaluation reports and labeling.

Tools & Technologies:

• ISO standards (13485, 14971), FDA portals

• Document control tools (QMS software or Google Workspace)

Real-Time Projects:

• Technical File preparation for ventilators

• Risk management file based on ISO 14971

• Predicate comparison reports (for FDA)

Ideal For:Biomed/Healthcare/Pharma students interested in regulatory affairs, med device documentation, or quality assurance.