MedDevice Development Immersion is a two-day course examining all aspects of medical device development. Starting with an overview of the different types of devices and the different industry sectors, the course then delves into the changing regulatory environment. This includes a discussion of the different regulatory pathways and a comparison of FDA vs. EU approval processes. The five phases of medical device development – market opportunity, evaluation, design, verification, and manufacturing – are described in detail. Develop an understanding of the entire process required to bring a new medical device to market.

Day One
Medical Device Overview 9:00–10:30
Medical Device Defined
Medical Device Diversity
Industry Sectors & Top Companies
History of Device Regulation
FDA Approval Pathways: 501(K) & PMA

Break 10:30–10:45

Medical Device Regulations 10:45–12:00
Quality System Regulations (QSRs)
Risk Management Plan
Exemptions
Rest of World Approval Pathways
Special Categories:
Home Brew & Combination Devices

Lunch 12:00–1:00

Medical Device Regulations continued 1:00–2:00
Regulatory Challenges
Diagnostics
Predicates
New Technologies
Clinical Trials
Medical Device Reporting

Medical Device Development 2:00–4:15
Phase I: Market Opportunity Evaluation
Market Analysis
Risk Management Plan
Phase II: Concept Evaluation
Formulation Steps
Feasibility
Phase III: Engineering Design Process
Design & Development
Software Development
Prototyping

Q&A|Review 4:15–4:30

Day Two
Medical Device Development 9:00–11:00
Phase IV: Verification
Phase V: Manufacturing Transfer
Documentation
Equipment IQ/OQ/PQ
Biocompatibility
Sterilization
Shipping & Storage

Break 11:00–11:15

Medical Device Approval 11:15–1:00
Clinical Trials
Need for a “Gold Standard”
Regulatory Submissions
Business Preparations
Product Launch Preparations
Coding & Reimbursement

Lunch 12:00–1:00

Medical Device Approval 1:00–2:30
Business Preparations
Product Launch Preparations
Coding & Reimbursement

Break 2:30–2:45

Commercialization 2:45–4:15
Manufacturing Scale-Up
Product Launch
Post-Launch Assessment

Wrap-Up 4:15–4:30


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  • Deliverables | Course Book, Certificate of Attendance
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