QUALITY ASSURANCE
REGULATORY AFFAIRS
Regulatory Affairs focuses on the rules, guidelines, and approval processes required to ensure that medical devices, pharmaceuticals, and healthcare products meet quality, safety, and regulatory standards.
Course Overview
The Regulatory Affairs course provides knowledge of regulatory guidelines, product registration, documentation, quality management systems, and compliance requirements in the healthcare and medical device industries. Students learn about medical device regulations, product approval procedures, risk management, technical documentation, and quality standards. This course helps develop the skills required to support regulatory compliance and pursue career opportunities in medical device companies, pharmaceutical industries, quality assurance, and regulatory affairs departments.
Curriculum & Practical Syllabus
Module 1: Foundations & Equipment Overview
- Core principles
- Instrumentation setup