Medical Device Engineering Lunch & Learn

Heurnova’s Medical Device Engineering Lunch & Learn Series delivers compact, high-impact sessions designed to introduce teams, students, and new engineers to the key concepts that drive safe, compliant, and innovative medical device development. These sessions distill complex regulatory, engineering, and quality topics into digestible, engaging discussions that fit within a standard lunch hour — without sacrificing depth or practical insight.

Whether hosting a single session or booking a full multi-week series, attendees walk away with a clear understanding of how design controls, risk management, validation, documentation, and post-market feedback shape the entire medical device lifecycle.

Perfect For...

University engineering programs
New-hire onboarding
Cross-functional teams
R&D, QA/RA, and manufacturing groups
Professional development events

Core Topics (Mix & Match)

Each Lunch & Learn can stand alone or build into a customized series. Popular topics include:

Introduction to the Medical Device Lifecycle

From concept → design → validation → release
Device classifications & regulatory pathways (510(k), PMA, CE)
How engineering decisions impact safety and compliance

Design Controls & Traceability

Design Inputs, Outputs, Verification, Validation
How requirements link across the Design History File (DHF)
Real-world examples of gaps found in audits

Risk Management & FMEA Fundamentals

ISO 14971 principles
How DFMEAs and PFMEAs guide design choices
Integrating risk files into continuous improvement

Engineering for Compliance

Why “compliance is design”
Communicating like a design assurance engineer
Balancing innovation with risk-based thinking

Documentation & QMS Essentials

SOPs, work instructions, forms, and records
Document control and revision practices
The difference between evidence and justification

Validation Basics (IQ/OQ/PQ)

When each qualification stage applies
The difference between verification vs. validation
How to build defendable protocols and reports

Post-Market Surveillance & Continuous Improvement

Complaints, NCRs, CAPAs
How feedback loops drive design changes
Feeding complaint and CAPA data back into FMEAs

Regulatory Deep Dives

FDA 21 CFR 820 essentials
ISO 13485 overview
EU MDR technical file requirements

Format Options

Single Lunch & Learn (1-Hour)

One focused topic
Includes Q&A and takeaway summary sheet
Ideal for quick upskilling or onboarding

Mini-Series (3 Sessions)

Choose any three core topics
Builds foundational understanding across teams
Great for universities or new-hire cohorts

Full Lunch & Learn Series (6–8 Sessions)

Covers the complete device lifecycle
Includes optional mini-exercises (traceability, FMEA scoring, mock complaint review)
Provides a holistic, end-to-end perspective

Deliverables

Depending on the format selected, participants receive:

Topic summary sheets
Sample templates (DHF index, basic FMEA sheet, CAPA flow example, validation diagram)
Optional certificate of participation
Custom slide deck tailored to your program or department

Who Should Attend?

Engineering students
New engineers entering the medical device industry
Cross-functional teams (R&D, QA, RA, Manufacturing)
Universities hosting career-readiness workshops
Organizations strengthening design control awareness

Learning Outcomes

After attending, participants will be able to:
Describe the key phases of the medical device lifecycle
Understand design control terminology and documentation flow
Recognize regulatory expectations and compliance risks
Follow how risk and complaints feed into continuous improvement
Communicate more effectively in cross-functional, regulated environments

Get a Quote

Every organization's compliance journey is different — your quote should be too.

Share a few details about your project at contact@heurnova.com, and we'll prepare a customized quote.

Alternatively, you can drop your information below, and we will reach out to you: