This article focuses on BSI’s new White Paper Series for the Medical Devices & IVD’s industries, First one on the EU Proposed Regulations 9 April 2014 – Today marks the beginning of a series of white papers that BSI has
IEC 60601-1, 3rd ed. related standards changes & new Interpretation Sheet 3
IEC 60601-1, 3rd ed. has been out for about 7 years now and there have been lots of changes within the IEC 60601 series of standards to align with 3rd edition.
Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance
Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to
RAPS & Medicaldeviceslegal.com EU Medical Devices Regulation Chart
This Regulation Chart & the blog post contents is Thx to Medicaldeviceslegal.com and the RAPS Dutch/Flanders chapter. We are grateful to them for sharing such a valuable tool and hope you get a lot of good use from it too. All they
Reminder Presentation on IEC60601-1, 3rd edition, Amendment 1 & its Impact on Users on 2 May ’13
Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users” at an FX Conferences event on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to