This post covers 8 product codes added & updates made to the guidance on Device Classes Exemptions from Premarket Notifications Requirements On Aug 14, 2015 FDA updated the Final Guidance Document titled “Intent to Exempt Certain Unclassified, Class II, and
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
IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published
IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published This post discusses the recently published Guidance IEC TR 60601-4-3:2015 that issues interpretations of IEC 60601-1, 3rd ed. and edition 3.1. The technical report tiled IEC TR 60601-4-3:2015
Guidelines for Medical Device Safety Testing – AAMI TIR62354:2015
Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing. AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”. This report is available from AAMI