Medical Devices and Diagnostics

The medical device industry continues to see healthy growth, especially the in vitro diagnostics market. Pharma IQ is proud to provide an international, non-biased, central resource, for professionals working in the bio-pharmaceutical and medical device industry to exchange ideas on best practice and share case studies on innovation within the area.

Industry Wide Extractables Study Design Data To Go Live this Quarter - Chanice Henry

An improvement in the current patchwork level of understanding is said to be on the horizon. Earlier this year Chemic Laboratories Inc. declared its corporate commitment to generate analytical data on the BOSA and BPOG study designs and independently assess proposed extractables methodologies. Full Article »

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How To: Scalable Unique Device Identification (UDI) Implementation – Real World Lessons Learnt - Andrea Charles

“ Barcodes aren’t glamorous or sexy, but they are powerful,” said Dawn Fowler, Sr. Manager, Labeling & Documentation at Endologix. In this exclusive Pharma IQ interview Dawn Fowler speaks about the importance of real world assessment in executing UDI programs and imparts scalable ways to implement unique identifiers for medical devices. Fowler also shares her top 3 tips for implementing UDI Information on a medical device, and insights into the common pitfalls manufacturers make when they are just setting out. Full Podcast »

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Medical Device UDIs: What You Need to Know

Contributor: Regina Au
Posted: 4/7/2015

Medical Device UDIs: What You Need to Know - Regina Au

In 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 device industry, both in the US and on a global scale. Au also reveals the 5 key business benefits for medical device manufacturers. Full Column »

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Updated for 2015 - The UDI Final Rule Interactive Compliance Calendar

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 technical capabilities - both hardware and software - and work out how much they need to do in order to comply. Ahead of the Medical Device UDIs & Traceability Forum, taking place 26 - 28 May, 2015 in Munich, Germany, Pharma IQ has put together this one-page compliance calendar to help you understand what impact the September 2013 FDA Final Rule on unique device identification will have on your business. Full Whitepaper »

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