MedTech Product Development (edX)

Have an idea for a Health Technology device, but don't know where to begin? ***

Course 2: Product Development is the second course in the MEDTECH FUNDAMENTALS by NEMIC Virtual Classroom Certificate Program, and serves to take a deep-dive into the highly-regulated MedTech commercial space. Course 2 contains 6 modules:

- Product Development 101

- Research Usability + Human Factors

- Product Development 102

- Regulatory Affairs 101

- Quality Assurance 101

- Clinical Trials + Validation

Researched, developed, and delivered by industry professionals from some of the world's most admired and successful companies in Health Tech, Product Development will both broaden and deepen the learners' knowledge in the space.

In this course, NEMIC Advisors will guide you through a series of activities that will break down barriers to FDA navigation, multi-phase development of a med device, unpack clinical trials, and more.

Come experience the most succinct, comprehensive MedTech education available.

This course is part of the MedTech Fundamentals by NEMIC Virtual Classroom Professional Certificate.

What you'll learn

Product Development 101:

- Development lifecycle

- Multi-phase development approach

- Discovery, engineering + verification

Research Usability + Human Factors:

- Human-centered design specifications

- Usability research

- Risk mitigation, minmize user error

- Verification + validation testing concepts

Product Development 102

- Multi-phase development approach [continued]

- Pilots

- Post-market surveillance

Regulatory Affiars:

- "Laws" of the MedTech world

- Key regulatory concerns and requirements

- FDA submission requirements

Quality Assurance 101:

- FDA quality requirements navigation

- FDA systems navigation

- How to avoid costly pitfalls

Clinical Trials + Validation

- Various types of clinical trials

- How to plan and manage clinical trials

- How to partner with clinical research organizations [CROs].