Design Controls in Practice | BIOMEDevice Boston

Design Controls in Practice: Building a Lean, Audit-Ready Development Process

Build a development framework that satisfies FDA and ISO 13485.

#MEDeviceBoston

Design Controls That Protect Your Product Without Slowing It Down

This interactive workshop guides you through building a lean, audit-ready development framework aligned with FDA and ISO 13485 expectations. Walk away knowing how to structure documentation, manage risk, and maintain traceability without overwhelming your team or stalling innovation.

SAVE THE DATE

Why Attend this Workshop

Traceability Mastery

Learn how to build and maintain a traceability matrix that links user needs, inputs, outputs, and verification.

Risk Integration

Know how to integrate ISO 14971 risk management directly into your development process.

Audit Readiness

Discover what FDA inspectors look for in design controls and how to prepare your documentation.

Deficiency Prevention

Explore the most common FDA design control deficiencies and the practical steps to avoid them.

Workshop Breakdown

Everything you need to build an audit-ready process from day one.

Design Control Fundamentals
Work through the core elements of an effective, right-sized design control system.
Design History File
Build and maintain a practical DHF structure that satisfies FDA expectations.
Traceability Matrix
Create clear traceability from user needs through design inputs, outputs, and verification.
Deficiency Identification
Work through common FDA design control deficiencies and identify gaps in your current process.
Inspection Preparation
Run through an inspection readiness exercise to test your documentation.

Who Should Attend

Quality & Compliance Professionals

Quality Assurance Engineers
Quality Systems Managers
Compliance Officers
Validation Engineers
Document Control Specialists

Engineering and R&D Professionals

Product Development Engineers
Design Engineers
Biomedical Engineers
Systems Engineers
R&D Leaders and Program Managers

Regulatory and Business Leaders

Regulatory Affairs Specialists
Regulatory Affairs Managers
Startup Founders and Executives
Product and Program Managers
Operations Managers

Get More With the Full Conference Pass

Get full access to all conference education, workshops, and expo sessions at MEDevice Boston when you register for the MEDevice Conference. Claim your pass and learn the complete framework for building, scaling, and growing a successful medical device company.

What’s Included With Your Conference Pass

Every Hands-On Workshop

Right-Sized Quality Systems, Regulatory Strategy Lab, Design Controls in Practice. Solve the full spectrum of compliance and development challenges.

Three Conference Tracks

Every session covering regulatory updates, MedTech technology, and growth & investment strategies over two full days of expert-led content.

The Full MEDevice Experience

200+ exhibitors, show floor education, the Innovation Lab, networking events, and complimentary refreshments across both days.

LEARN ABOUT THE CONFERENCE ○ VIEW PASSES & PRICING

2026 Call For Speakers! Submit Your Proposal — LEARN MORE