Medical Device Compliance & Certification Summit

Navigating Compliance for Medical Devices

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 how to:

✔ Navigate electrical safety and risk-based requirements under IEC 60601-1
✔ Understand U.S., Canada, and EU regulatory pathways — including FDA and MDR
✔ Build successful EMC and RF compliance strategies (including coexistence & SAR)
✔ Prepare complete and defensible 510(k) submissions
✔ Integrate cybersecurity requirements into safety and essential performance
✔ Prepare for future standards, including IEC 60601-1 4th Edition and IEC 61326-2-6 (2025)

With ESC contributing additional expertise in safety engineering, design documentation, global submissions, and quality system expectations, attendees will gain a deeper understanding of what regulators and certifiers look for, and how to present compliant, well-structured documentation that speeds approval rather than slows it down.

Day 1 – Electrical Safety, IEC 60601 Series & Global Frameworks

From international regulatory pathways to understanding IEC 60601-1 structure, Day 1 builds the foundation for device safety and certification success.

Key topics include:

• FDA, Health Canada & EU MDR regulatory pathways
• IEC 60601-1 general, collateral, and particular standards
• Test plan development, sample requirements, and documentation
• EMC expectations, global deviations, and RFID immunity testing
• RF compliance: coexistence, SAR, and global market access
• How to build a passing FDA submission & avoid common errors

Day 2 – EMC/RF, Cybersecurity & Future Standards

Day 2 focuses on advanced challenges: wireless technology, cybersecurity enforcement, and upcoming standards that will impact future product approvals.

Key topics include:

• FDA & MDR cybersecurity requirements (SBOM, patching, pen-testing)
• IEC 81001-5-1, UL 2900-1 and cybersecurity evidence for submissions
• Preparing for IEC 60601-1 4th Edition
• When a device falls under IEC 61010 instead of 60601
• EMC for IVD devices under IEC 61326-2-6 (2025)
• MDR technical documentation and Notified Body expectations

The day ends with a live roundtable Q&A, allowing attendees to ask direct questions about their devices, challenges, and compliance strategies.

Day 3 – Hands-On Workshops (Optional Add-On)

Attendees may choose one of five intensive labs designed to produce real deliverables they can use immediately:

1. Build a 60601 Test Plan
2. EMC/RF Failure Analysis Case Lab
3. Cybersecurity File Sprint
4. FDA 510(k) Mock Submission
5. Risk Management & Essential Performance Traceability Lab

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