Curriculum
- 5 Sections
- 19 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Foundations of the MedTech Ecosystem4
- Global Regulatory & Market Landscape4
- 2.1Global Regulatory & Market Landscape: FDA (QSR → QMSR), EU-MDR / IVDR, MDSAP, India MDR 2017, NMPA (China)
- 2.2Interplay of Quality (QMS), Risk-Management (ISO 14971), Clinical-Evidence (ISO 14155 / GCP)
- 2.3Industry Trends & Headwinds
- 2.4Typical cross-functional pain-points between R&D, QA/RA, manufacturing, marketing
- Industry Case Studies – Lessons from the Field5
- 3.1Case 1 – 510(k) vs De Novo submission strategy for a Class II device
- 3.2Case 2 – EU-MDR transition challenge: re-classification and clinical-evidence gaps
- 3.3Case 3 – Post-market surveillance signal leading to field corrective action
- 3.4Case 4 – SaMD start-up scaling hurdles: cybersecurity + data-privacy compliance
- 3.5Lessons from audits, recalls, & global launches
- Interactive Workshops & Decision-Making Simulations4
- 4.1Lifecycle mapping exercise: map your own product / service to MedTech lifecycle stages
- 4.2Stakeholder-role play: cross-functional decision-meeting on risk vs speed-to-market
- 4.3Mini-simulation: Appropriate regulatory pathway & evidence package for a sample product
- 4.4How decisions affect compliance, timelines, and cost-to-market
- Wrap-Up & Key Take-Aways2
Holistic understanding of MedTech ecosystem & terminology.
Prev