Eisner Safety Consultants delivers strategic medical device compliance and regulatory support across U.S., Canadian, European, and global markets.

Founded by Leonard “Leo” Eisner, widely known as The IEC 60601 Guy, we help manufacturers of active medical devices, drug device combination products, IVDs, and active implantables achieve affordable, on time product approvals through test laboratories, regulatory agencies, notified bodies, and quality system certifiers.

We integrate compliance early and execute it precisely through:

  • Design for IEC 60601 and related standards
  • EMC and safety test planning
  • Risk management integration
  • Technical documentation and EU MDR support
  • Labeling compliance, including UDI, IEC 60601 series, ISO 15223, ISO 20417
  • Test lab coordination and regulatory submission strategy

With over 20 years at the forefront of global standards development, including leadership roles in the ongoing development of IEC 60601-1 4th Edition and active participation in IEC 60601-1 Ed. 3.2, Leo brings unmatched standards insight combined with practical regulatory execution.

Our approach combines deep standards insight with practical regulatory strategy, helping clients navigate the medical device compliance landscape with clarity, precision, and confidence.