Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an
FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices
On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”. The Guidance was developed to describe the types of information that the FDA expects to be
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
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,
Welcome Mary Weick-Brady to Eisner Safety Consultants
I am thrilled to announce our latest addition to the Eisner Safety Consultants team Mary Weick-Brady recently joined our team and will help us support a growing need for the Wearable Medical Devices and the Home Use Medical Markets. Ms. Weick-Brady comes with