Deep Dive Medical Device Development Immersion

Deep Dive Medical Device Development Immersion
  • Level: Beginner
  • CPE: 11.5 Credits
  • Time: 10 Hours
  • Price: $895.00 for 1 year

Medical Device Development Immersion takes you inside the fast-moving world of device innovation, from market evaluation to design, regulatory approval, and manufacturing. Learn proven strategies for success through real-world insights and an interactive prototype-building activity.

  1. Learn the lifecycle of medical device development to better evaluate investment opportunities.
  2. Gain insight into the regulatory, design, and quality requirements that impact time-to-market and commercial success.
  3. Discover the strategies that align product development with user needs, regulatory demands, and business goals to drive market adoption.
  • Best Value: Unlimited Learning
  • Purchase Single Course

Choose your subscription and start exploring a rich library of expert led, on-demand biotech training.

  • Up to 12-month unlimited access
  • Content designed for all skill levels: Beginner to Advanced
  • CPE credits included with every course
  • Learn at your own pace
  • Choose the subscription plan that fits your goals

Get full access to this course with a one time purchase.

  • 1-year access to all course material
  • CPE credits included
  • No subscription required
  • Self-paced and on-demand
  • Ideal for focused, one-off learning
  • Overview
  • Agenda
  • Features
  • Justify This Training
  • FAQ

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Agenda

  1. Medical Device Overview

    Explores the FDA’s regulatory history, mission, and what defines a medical device, including software, diagnostics, mobile devices, and wellness products.

  2. Regulatory Approval Pathways

    Examines device classifications and approval pathways, including 510(k), de novo, Class III exemptions, and combination products.

  3. Medical Device Regulation

    Highlights regulatory compliance, including GMP, GLP, and GCP, as well as FDA enforcement actions.

  4. Phase I – Market Opportunity Evaluation

    Explores development timelines, design regulations, and market evaluation strategies through a practical customer needs assessment for a Bionic Walker.

  5. Phase II – Concept Evaluation

    Discusses risk analysis planning, risk matrix development, and risk quantification using a real-world concept evaluation of the Bionic Walker.

  6. Phase III – Engineering Design

    Teaches core engineering design principles, including software development and design documentation, with application to the Bionic Walker prototype.

  7. Phase IV – Verification and Validation

    Showcases strategies for product testing, labeling verification, biocompatibility, and human factors, all applied to the Bionic Walker design.

  8. Phase V: Manufacturing

    Examines key manufacturing factors, technology transfer, and scale-up strategies essential to optimizing device production.

  9. Medical Device Approval

    Explores the FDA approval process, including pre-submission meetings, submission types, expanded access, and MDUFA timelines.

  10. Commercialization

    Highlights medical device commercialization strategies, including the roles of the FDA and CMS, and reimbursement.

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Viewable course workbook
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates

Justify This Training

View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.

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