Medical Devices and Diagnostics

The Institute of Medicine has called for a new regulatory framework to replaced 510(k), urging the FDA to invest in the development of a system featuring both premarket clearance and improved post-market surveillance. "The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one," the committee noted in the report. Full Article »

Human factors principles and practices are playing an increasingly important role in medical device design as manufacturers recognise the range of benefits. In this interview Dr. Edmond W Israelski, Director, Human Factors, Abbott Quality and Regulatory, Abbott, joins Pharma IQ, to discuss what will top AAMI’s Human Factors subcommittee agenda in 2011 -2012, the impact of the latest standard ANSI/AAMI HE75:2009 and what is next for medical device design. Israelski also shares his top tip for successfully applying human factors in design controls during the design of a medical devices and how to avoid common pitfalls in design. Full Podcast »

Since more and more clinical research and drug manufacturing are being done in multiple countries and in multiple languages, quality language services can help bring a drug to market faster, and can help streamline the clinical trial process. Translation may be required at many stages, including clinical research, regulatory submission and review, production and marketing. Full Column »

One of the most significant healthcare industry efforts of the 21st century is the national vision of connected and interoperable healthcare infrastructure. Full Whitepaper »