Program Overview
This program equips professionals with a holistic understanding of the MedTech ecosystem—spanning medical devices, diagnostics (IVDs), and software as a medical device (SaMD/MDSW). Led by an industry expert with over 25 years of global MedTech experience, the course combines conceptual foundations, regulatory context, market dynamics, and real-world case studies. Participants will gain fluency in key terminologies, lifecycle stages, global regulatory frameworks (FDA, EU-MDR/IVDR, ISO 13485, ISO 14971) and learn to navigate quality-risk-compliance trade-offs. Interactive exercises and simulations enable teams to apply learning to product decisions, cross-functional challenges, and go-to-market strategies, fostering collaboration across R&D, QA/RA, operations, and commercial teams.
Features
- Explain the MedTech product lifecycle and its impact on compliance and market timelines
- Recognize global regulatory pathways and their business implications
- Relate risk-management, quality, and clinical-evidence requirements to cross-functional decision-making
- Apply real-life cases to resolve compliance, market-access, and stakeholder challenges effectively
Target audiences
- R&D Engineers
- QA/RA Teams
- Product Managers
- Clinical Affairs Professionals
- Manufacturing & Operations Teams
- Supply-Chain, Commercial/Sales & Marketing Professionals
Curriculum
- 5 Sections
- 19 Lessons
- 1 Day
- 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
Instructor
