FDA Medical Device Training Suite

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Project case study (STAR)

Comprehensive training suite for medical device sales and clinical support teams meeting FDA requirements.

Sep 1, 2024

324 views

FDAMedical DeviceHealthcareSales TrainingCompliance

Impact & Results

850

Learners Reached

98%

Completion Rate

100%

audit compliance

98%

launch-window completion

regions deployed

0 findings

promotional review on training

5 months

Project Duration

ADDIE

Methodology

Freelance Instructional Designer

Designer Role

Healthcare Training

Step 1 — The Situation

Field teams needed consistent, audit-ready messaging on a complex device portfolio while protecting confidential launch details under NDA.

Step 2 — The Task

As a Freelance Instructional Designer, I led the end-to-end design and development of this project — from discovery and needs analysis through final delivery and implementation support.

Process timeline

ADDIE Process

Analyze

Identify needs, learners, and goals

Design

Create learning objectives and strategy

Develop

Build content and materials

Implement

Deploy training to learners

Evaluate

Measure effectiveness and iterate

Analyze

Identify needs, learners, and goals

Design

Create learning objectives and strategy

Develop

Build content and materials

Implement

Deploy training to learners

Evaluate

Measure effectiveness and iterate

Project timeline

3 updates

Apr 1, 2024milestone

Legal & regulatory alignment workshop

Jun 10, 2024milestone

Pilot with clinical specialists

Sep 1, 2024milestone

National rollout + LMS packaging

Step 4 — The Solution

A modular curriculum mapped to FDA promotional guidelines: role-specific pathways, attestations, and downloadable job aids with version control.

Step 5 — The Impact

Results (aggregated / approved for external sharing): - Audit-ready completion records across 12 regions - 98% course completion within launch window - Zero promotional review findings tied to training materials

Tools Used

Articulate 360Adobe CaptivateVeeva Systems

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