Quality Systems Workshop | BIOMEDevice Boston

Right-Sized Quality Systems for Growing MedTech Companies Workshop

Build a compliant, scalable QMS without overbuilding too early.

#MEDeviceBoston

Building a Quality System That Grows With You

This hands-on workshop is built for startups and scaling MedTech companies that need a practical, right-sized QMS aligned with ISO 13485 and FDA expectations. Walk away with the frameworks, tools, and confidence to build compliant processes without overengineering too early.

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Why Attend this Workshop

Practical Frameworks

Learn core QMS elements required at each stage of company growth, from seed to scale.

Lean Documentation

Navigate how to structure SOPs and documentation that satisfy requirements without creating unnecessary overhead.

CAPA and Complaint Handling

Discover the essentials for building effective CAPA and complaint handling processes from day one.

Inspection Readiness

See what FDA inspectors look for and how to prepare your team and documentation before they arrive.

Workshop Breakdown

The practical tools and frameworks to build a QMS that works for where you are right now.

QMS Roadmap by Stage
Work in small groups to build a QMS roadmap tailored to your company stage, whether seed, Series A, or growth.
SOP Refinement
Work through real SOP templates and refine them into lean, practical documentation.
Mock FDA Inspection
Run through a simulated FDA inspection scenario to identify gaps and test your readiness.
CAPA Flow Exercise
Build a simple, functional CAPA flow your team can implement immediately after the workshop.

Who Should Attend

Quality & Compliance Professionals

Quality Managers
Quality Assurance/Systems Engineers
Compliance Officers
CAPA Specialists

Regulatory Professionals

Regulatory Affairs Specialists
Regulatory Affairs Managers
Validation Engineers
Document Control Specialists

Business & Operations Leaders

Startup Founders and Executives
Operations Managers
Product and Program Managers
R&D Leaders at Early-Stage Companies

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.

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