Eisner Safety Consultants

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 GHTF left behind when it was decommissioned in the last. In another post I will [...]

A new LinkedIn group has been formed thx to the support of the IEC (International Electrotechnical Commission)*.  The group name is the IEC 60601 series of standards on Medical Electrical Equipment.  This group is not just about the 3rd edition of IEC 60601-1 but about the whole series of IEC 60601 series of standards and [...]

On 4 Jan 2013 the FDA issued, in the Federal Register, a notice of Public Workshop entitled “Accessible Standardized Medical Device Labeling”.  FDA indicated the focus of the workshop is to “discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare [...]

On 12 December 2012 the FDA issued a new Draft Guidance for Industry & FDA Staff on Design Considerations (for design and development) for Devices Intended for Home Use. Back in April 2010 the FDA launched the Medical Device Home Use Initiative as there were concerns of the growing number of safety issues with medical [...]

As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information.  In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation of the GHTF’s” 20 years and the aim is to “accelerate international medical device regulatory harmonization [...]