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.

The FDA are Taking Cybersecurity in Medical Devices Seriously and So Should You - Gerald Clarke

Medical devices are undergoing a technical transformation in terms of software, interconnectivity and interoperability. This increase of function comes with an increase in risk from cybersecurity threats which puts not only the patients with medical devices potentially at risk, but has wider implications for connected digital infrastructure too. The safety, security and privacy of patients must be protected and the providers of software for medical devices must work with regulators and the wider industry to ensure this. 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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From High Tech to MedTech

Contributor: Regina Au
Posted: 3/23/2015

From High Tech to MedTech - Regina Au

In the medtech world, the boundaries between the semiconductor and medtech industries have already been blurred with chips, sensors and Micro-Electro-Mechanical Systems (MEMS). Today, the boundaries between high tech and medtech are starting to blur as well. 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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