Eisner Safety Consultants: Qmed Qualified Supplier

Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants

Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.) Our […]

Join Us @ RAPS Regulatory Convergence Discuss Wearable Devices 26 Oct ’15

Join Us at RAPS Regulatory Convergence Conference on Monday October 26, 2015 to Discuss Wearbale Devices Topic: “Wearable Devices: How to Make Them Safe and Adhere to Regulations” Presenters: Leo Eisner & Mary Weick-Brady of Eisner Safety Consultants and Bakul Patel of OC, CDRH, FDA Session Leader: Seth Goldenberg, PhD, director, Global Regulatory Strategy, NAMSA When: October 26, 2015 […]

Standards Reconnaissance Subscription Service Coming Soon

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 effort does it take to keep the list updated? If this is a struggle for […]

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 ed. 3.1) is being used by Regulatory & Standards Organizations for the USA and Canada. […]

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 Guidance & interpretation – Considerations of unaddressed safety aspects in the 3rd ed of IEC […]