FDA Guidance Document – Eisner Safety Consultants

FDA Adds Interpretation Sheet 1 on Essential Performance & SFC of IEC 60601-1 to AAMI ES60601-1 Recognitions DB

The FDA on May 30, 2022, same day as when the recent AAMI 60601 Amendments were Recognized, added the Interpretation Sheet 1 (ISH1) – Amendment 1 – on Essential Performance (Clause 4.3) and Single Fault Condition (Clause 4.7) based on

Back by Popular Demand – Wearable Medical Devices – FDA’s Current Thinking

As this presentation was so well attended in July FX Conferences has decided to rerun this presentation twice in August so those that missed it can obtain this critical information for the Wearable Medical Device industry. Leo Eisner will be

Presentation on Wearable Medical Devices – Current Thinking from FDA

Leo Eisner will be speaking on Medical Device Wearables and the Current Thinking from FDA with respect to myriad of new guidance documents that may apply to your devices. This presentation is being offered 2 times in July (Tuesday July