Medical Device Compliance & Certification Summit

February 2-4, 2026 • In-Person Training & Live Workshops

Location: Carlsbad Inn Beach Resort, 3075 Carlsbad Blvd, Carlsbad, CA 92008

Bringing a medical device to market has never been more challenging. Between evolving IEC 60601 requirements, global EMC/RF rules, cybersecurity enforcement, and increasingly complex FDA/MDR submissions, manufacturers are being held to higher technical and regulatory expectations than ever before.

This year, Nemko is proud to partner with Eisner Safety Consultants (ESC) to deliver a comprehensive three-day program designed for engineering, regulatory, and compliance teams. Together, our experts bring decades of practical experience in safety testing, regulatory pathways, technical documentation, and global approvals — giving attendees a clear, real-world roadmap to certification success.

Whether you’re preparing a new device for market, facing recurring test failures, or working through FDA or MDR technical documentation, this summit delivers the guidance, tools, and hands-on learning needed to accelerate approvals and avoid costly delays.

What You Will Learn

Across two days of expert-led training and a full day of hands-on workshops, attendees will learn:

• Regulatory Landscapes: U.S., Canada, and EU
• Future Impacts of IEC 60601-1 4^th ed
• Essential Performance
• Risk Management & Collateral Standards
• Making Standards Your Competitive
• Advantage - Reduce Design Cycle & Time to Market
• EMC Compliance for Medical Devices
• RF Compliance for Medical Devices
• Cybersecurity for Medical Devices (FDA & EU MDR)
• Beyond 60601 – IVD & Lab Equipment
• Evaluation, Testing & Certification
• Understanding FDA Submissions for Medical Devices
• Medical Device Regulation (MDR) Requirements

Optional: Hands-On Workshops

• Build a 60601-1-2 EMC Test Plan
• Risk Management & Essential Performance Traceability
• EMC /RF Failure Analysis Case
• Cybersecurity File Sprint

Each workshop includes templates, checklists, and working files that attendees can take back to their teams.

Pricing

• Days 1–2: $1,500
• Optional Day 3 Workshops: +$1,200
• Full 3-Day Access: $2,500

Early-bird: 10% off if registered by 12/31/25.
Group pricing available — email your sales rep.

Who Should Attend

• Electrical, EMC, RF & systems engineers
• Regulatory affairs & quality personnel
• Product managers, compliance managers, and device manufacturers
• Startups preparing for first submission
• Teams facing test failures, redesigns, or certification delays

Why Attend

✔ Learn directly from medical device compliance experts
✔ Avoid costly redesigns and repeated testing
✔ Accelerate global approvals and reduce regulatory risk
✔ Get real templates, tools, and checklists you can implement immediately
✔ Optional hands-on workshops offer direct, practical experience