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Presentation on Navigating FDA’s Home Use Medical Devices Draft Guidance
Leo Eisner will be presenting on the topic “Navigating FDA’s Draft Guidance on Home Use Medical Devices” at an FX Conferences event on 11 July, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern).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
UK MHRA Guidance on EU Regulation 207/2012 on electronic labeling of med dvcs
On 9 Jan 2013 the UK MHRA (The Medicines and Healthcare products Regulatory Agency) released a Guidance on EU Commission Regulation 207/2012 on electronic labeling of medical devices. This regualtion came into force on 1 March 2013 so you can
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
IMDRF Draft Guidance Doc’s Out for Comment: UDI & 3rd Party Audits
The International Medical Device Regulators Forum (IMDRF) has been really busy of late, which is a good thing as many in the medical device industry are still wondering if the IMDRF will live up to the “Big Shoes” that the