Medical Device Compliance & Certification Summit – Why It Matters?
Medical device and diagnostic compliance expectations are shifting earlier in the product lifecycle. IEC 60601 and related standards are no longer something teams can “handle at test.” Regulators increasingly expect standards interpretation, risk decisions, and test strategy to be visible and justified during design reviews and technical documentation development.
This shift is showing up in real ways – deeper design reviews, tougher pre-submission questions, and increased scrutiny of how standards were applied, not just whether a final test report exists.
To address this reality, Eisner Safety Consultants (ESC) is working with Nemko to deliver a three-day, in-person Medical Device Compliance & Certification Summit focused on how standards, testing, and regulator expectations intersect in real programs.
A focused, three-day program for engineering, regulatory, and compliance teams navigating IEC 60601, IEC 61010, EMC and RF requirements, certification strategy, and regulator guidance documents across FDA, EU, and other markets.
In-Person Training & Live Workshops
February 2–4, 2026
Carlsbad Inn Beach Resort, 3075 Carlsbad Blvd, Carlsbad, CA 92008
Designed for teams preparing new medical devices or diagnostics for market, working through recurring EMC or RF failures, or tightening FDA or EU MDR technical documentation ahead of submission or surveillance review.
Who this summit is designed for
- Electrical, EMC, RF, and systems engineers
- Regulatory affairs and quality professionals
- Product and compliance managers
- Medical device and diagnostic startups preparing first submissions
- Teams facing test failures, redesigns, or certification delays
What attendees will learn
- How regulators evaluate standards application, not just test outcomes
- Future impacts of IEC 60601-1, 4th edition concepts on design controls
- Essential Performance and its role in risk management and review discussions
- How EMC and RF strategies influence certification timelines
- When IEC 61010 applies to diagnostic and laboratory equipment
- Cybersecurity expectations under FDA and EU MDR
- How guidance documents shape FDA and EU technical file expectations
How Eisner Safety Consultants Can Help
As regulatory expectations increase, delays are often caused by unclear standards interpretation, weak traceability between design decisions and requirements, and technical documentation that does not explain why choices were made.
Eisner Safety Consultants works with medical device, diagnostics, and combination device manufacturers every day to translate IEC 60601, IEC 61010, and related standards into practical design inputs, defensible test strategies, and documentation that aligns with FDA, EU, and other regulator guidance documents.