Medical Device Engineering Seminar

Our Medical Device Engineering Seminar introduces participants to the full lifecycle of medical device development — from concept through post-market surveillance — combining practical engineering design principles with the regulatory and documentation frameworks that govern the industry.

Designed for universities, new engineers, and transitioning professionals, this seminar bridges the gap between theory and industry practice, providing the knowledge and context needed to navigate the complexities of design controls, validation, and continuous improvement within a regulated environment.

Attendees gain a holistic understanding of how design decisions impact safety, compliance, and product performance — and how every activity, from brainstorming concepts to managing complaints, ties into a living quality management system.

Seminar Goals

By the end of the seminar, participants will:

Understand the design and development process from concept to commercialization.
Learn how design documentation, risk management, and validation interconnect.
Recognize the regulatory expectations driving documentation (FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR).
Understand post-market surveillance and how complaints, NCRs, and CAPAs feed back into FMEAs and design improvements.
Gain real-world insight into quality culture, audit preparation, and effective engineering communication.

Key Topics Covered

1. Design Process Fundamentals

Design Control elements and stage-gate methodology
Design Inputs, Outputs, Verification, and Validation
Risk-based design and traceability from user need to market release
Design history file (DHF) and technical documentation requirements

2. Documentation & Traceability

Structure of documentation hierarchy (SOPs, WKIs, forms, records)
Document control and versioning practices
How to maintain traceability using matrices and linking tools
Real examples of compliant design documentation

3. Validation & Verification

Differentiating verification vs. validation
When IQ, OQ, and PQ apply to product and process development
Statistical and practical considerations in validation studies
Integrating validation results back into risk management

4. Regulatory Landscape

Overview of FDA, EU MDR, ISO 13485, and ISO 14971 frameworks
How regulations translate to daily engineering activities
Design control audits and what inspectors look for
Understanding 510(k), PMA, and CE marking pathways

5. Post-Market Surveillance & Continuous Improvement

Complaint handling, Nonconformances (NCRs), and CAPAs
Trending and data-driven corrective actions
How field performance and failures drive iterative design improvement
Feeding complaint and CAPA data into FMEAs and risk files

6. Practical Integration & Real-World Context

Role of cross-functional collaboration (engineering, quality, regulatory, manufacturing)
Common pitfalls and “hidden” design control challenges in startups and large companies
Developing engineering intuition in a regulated environment

Session Length Options

While we are flexible and can customize your session lengths, here are the most popular formats, catered to your team’s needs and depth of exploration:

Format	Duration	Ideal For	Focus
Two-Day Intensive	16 hours	Engineering departments, senior students, or multidisciplinary teams	Deep-dive into the full device lifecycle & includes mock design review, validation plan drafting, and post-market feedback simulation
Full-Day Seminar	8 hours	Capstone-style training or onboarding session	Expanded coverage with interactive case study, example DHF review, and CAPA/FMEA integration exercise
Half-Day Seminar	4 hours	Introductory overview for university classes, interns, or new hires	High-level introduction to design control, validation, and regulation with sample documentation walkthrough

Curriculum Overview

Half-Day Session – “Understanding the Framework”

Goal: Build awareness of the medical device lifecycle and introduce design and quality fundamentals.

Modules:

Introduction to Medical Device Design Controls
Understanding Risk and Documentation Flow
Overview of Validation & Regulatory Drivers
Continuous Improvement and Feedback Systems
Group Discussion: Real-World Scenarios

Deliverables:

Summary handouts and lifecycle diagram
Example documentation templates (Design Input form, FMEA sheet)

One-Day Session – “Applying Design Controls in Practice”

Goal: Connect concepts to applied scenarios and introduce students or engineers to regulatory expectations.

Modules:

Design and Development Planning – How Products Move from Idea to Market
Design Inputs/Outputs, Verification, and Validation Deep Dive
Understanding the Role of Risk: How FMEAs Guide Design
Documentation Review Exercise (Mock DHF Evaluation)
CAPA and Complaint Case Study – Feeding Post-Market Data Back Into Design
Q&A and Career Insights: Working in Regulated Industries

Deliverables:

Example DHF outline and traceability matrix
CAPA → FMEA feedback map
Certificate of Participation

Two-Day Intensive – “Lifecycle Mastery and Regulatory Integration”

Goal: Equip participants to understand and apply the complete lifecycle framework used by medical device companies.

Modules:

Day 1 – Design & Development Lifecycle

Concept-to-Commercialization Framework
Design Inputs, Risk Analysis, and Documentation Building
Validation Strategy (IQ/OQ/PQ) and Verification Integration
Mock Design Review and Documentation Evaluation

Day 2 – Regulatory Compliance & Continuous Improvement

Regulatory Body Deep Dive: FDA, ISO, EU MDR
Post-Market Surveillance and Complaint Management
CAPA, NCR, and Audit Simulation
FMEA Updating & Risk Escalation Exercise
Career Panel or Industry Discussion (optional)

Deliverables:

Full lifecycle visual map with design-to-post-market linkages
Template package (DHF index, FMEA, CAPA flowchart)
Certificate of Completion

Optional Add-Ons

Guest Speakers: Invite industry engineers or regulatory specialists for Q&A panels.
Template Kit: Editable Design Control templates for classroom or company use.
Certification Option: Co-branded certificate for university or internal programs.
Follow-Up Mini Workshop: 2-hour remote refresher or case study session after seminar completion.

Who Should Attend

Engineering or biomedical students interested in regulated product design
New or transitioning engineers entering the medical device industry
Cross-functional teams (R&D, QA, Regulatory) seeking an integrated view of the lifecycle

Outcomes

Participants leave with:
A complete understanding of how engineering design, risk management, and regulatory compliance intertwine.
Awareness of how every document and decision connects to patient safety.
Clear pathways to pursue roles in design assurance, validation, and quality engineering.

Get a Quote

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