Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 8, 2025. Turn Medical Device Standards into Your Competitive Advantage, and discover practical strategies to leverage standards, avoid costly errors, and accelerate your product development cycle.
Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn form the IEC 60601 Guy himself.:
- Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines
- Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions
- Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.
- Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays
- Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.
I want to thank Sean Smith and his team from 10X for all his help and dedication for putting on this event. He is doing an amazing job and please contact him if you are interested.
Need help with standards?
We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by
- Assisting with strategic compliance planning for your medical electrical product lines,
- Providing regulatory support when FDA or a regulator asks technical questions on your submission.
- Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.
- Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.
- We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance.
- Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more.
- Interfacing with test houses for medical safety, EMC and arrange other testing.
Feel free to schedule a web meeting with Leo or contact us.
