UDI
Medical Device UDIs: What You Need to Know
July 04 by Regina AuIn this Pharma IQ interview, Regina Au from BioMarketing Insight shares her insights on the current UDIs for medical devices landscape and the impact of the FDA’s final rule on UDIs on the medical dev...
Updated for 2015 - The UDI Final Rule Interactive Compliance Calendar
March 17 by Pharmaceuticals & Biotechnology EditorUpdated for 2015! The FDA Final Rule on unique device identification (UDI) for medical devices is out. Covering both labelling and the GUDID database, manufacturers need to assess their current...
THE UDI Final Rule Interactive Compliance Calendar
February 18 by Pharmaceuticals & Biotechnology EditorThe FDA Final Rule on unique device identification (UDI) for medical devices is out. Covering both labelling and the GUDID database, manufacturers need to assess their current technical capabilities...
GS1 Accredited as Issuing Agency for Unique Device Identification by the U.S. Food and Drug Administration
January 24 by Pharma IQNew Delhi (January 23th, 2014) –4 GS1, a leading global standards organisation, today received accreditation by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device...
UDIs for Medical Devices: Lessons Learnt from Cook Medical
July 24 by Pharmaceuticals & Biotechnology EditorThe FDA Final Rule on UDIs for medical devices is expected to be published in early August. Recently, the EU Commission announced their intention to take an internationally harmonised approach and f...
Lifting the Veil of Uncertainty: UDIs for Medical Devices
June 14 by Andrea CharlesThe FDA Final Rule on UDIs (unique device identifiers) for medical devices is expected to be published in early August. In May the EU Commission announced their intention to take an intern...
Balancing Act: Taking a Harmonised Approach to Medical Device Label Interoperability
May 20 by Melissa FinocchioIn this interview Melissa Finocchio, Director, Product Labeling and Documentation BioMerieux, speaks to Andrea Charles from Pharma IQ about changing trends in product labelling and documentatio...
European Commission's Laurent Selles on Medical Device UDIs: 60 Second Interview
May 20 by Laurent SellesThe FDA Final Rule on UDIs for medical devices is expected to be published in early August. Recently, the EU Commission announced their intention to take an internationally harmonised approach and f...
Coloplast's Inge Ørnhøj on Lessons Learnt from Implementing a UDI Labeling Project
May 20 by Inge ØrnhøjIn this exclusive interview Inge Ørnhøj, Senior Process Improvement Manager, Supply Chain Process Improvement at Coloplast A/S, speaks about the impact she thinks the regulation will h...
Impact and Implementation: Alere's VP for Regulatory Affairs on the US FDA Unique Device Identification System
May 20 by Simon RichardsAhead of the UDIs and Traceability for Medical Devices Forum 2014, Simon Richards, VP for Regulatory Affairs, EME at Alere, joins Andrea Charles from Pharma IQ to discuss the benefits of a well-buil...
GS1's Ulrike Kreysa on A Global Outlook to Unique Device Identifiers for Medical Devices
May 20 by Ulrike KreysaGS1, received on 17 December, 2013 accreditation by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs). In this interview, Ulrike Kreysa Vice Pr...
HOW TO: Realise ROI from your UDI Project
May 20 by Dawn FowlerIn this exclusive interview Dawn Fowler, Senior Manager, Labeling & Documentation Endologix, speaks to Andrea Charles from Pharma IQ about the benefits of UDI implementation beyond compliance a...