Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines? How much time does it take to put this list together and how much
FDA Updates Guidance on Device Classes Exemptions from Premarket Notifications Requirements
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
Scrip Regulatory Affairs Article on IEC 60601-1 for US & Canada
11 June 2015 – Scrip Regulatory Affairs – Article written by Leo Eisner titled “Everything you needed to know about who’s doing what where with IEC 60601-1 – Part 1” Article discusses how the standard (IEC 60601-1 3rd ed. or