About this course

If you have an idea for a Health Technology device but are unsure where to start, Product Development (Course 2 of the MEDTECH FUNDAMENTALS by NEMIC Virtual Classroom Certificate Program) presents a comprehensive introduction to the MedTech commercial space. This course offers six detailed modules ranging from basic to advanced topics, led by industry experts.

What students will learn

• The lifecycle and multi-phase development approaches of MedTech products.
• How to conduct usability research and implement human-centred design specifications to minimize user error.
• Understanding of FDA regulatory requirements and how to navigate them effectively.
• Strategies for effectively managing clinical trials and collaborating with clinical research organizations (CROs).

Prerequisites or skills necessary

It's beneficial and recommended to have taken "COURSE 1: MedTech Foundations" before enrolling in this course, particularly if you're not familiar with key MedTech industry terms and concepts.

Course Coverage

• Product Development 101: Basics of product lifecycle and development phases.
• Research Usability + Human Factors: Focusing on user-centered design and minimizing user error.
• Product Development 102: Advanced development strategies including post-market surveillance.
• Regulatory Affairs 101: Understanding MedTech laws and FDA submission processes.
• Quality Assurance 101: Navigating FDA quality requirements effectively.
• Clinical Trials + Validation: Planning and managing clinical trials.

Who this course is for

This course is ideal for anyone looking to enter the MedTech field or professionals already in the sector seeking to enhance their knowledge and skills in product development within highly regulated environments.

Applying these skills in the real world

Skills acquired through this course enable learners to navigate the complex regulatory landscapes of the MedTech industry effectively. Graduates can take on roles that involve product development, regulatory compliance, quality assurance, and clinical trial management, all crucial for successful MedTech innovation and compliance.

Course Syllabus

1. Introduction to Product Development in MedTech
2. Research Usability and Human Factors in Device Development
3. Advanced Product Development Strategies
4. Foundations of Regulatory Affairs in MedTech
5. Essentials of Quality Assurance
6. Execution and Management of Clinical Trials