Friday, May 10, 2013
FDA Medical Device Establishment Registration and Listing Regulations
By Jeff Crist - VP Quality and Regulatory at Cadence
Did you know that recent changes to the FDA Medical Device Establishment Registration and Listing Regulations (Title 21-CFR Part 807) require that all Contract Manufactures (CM) and Contract Sterilizers register their facilities with the FDA and list all finished medical devices manufactured or sterilized at those facilities? These changes took effect October 1st 2012 and the deadline to register was January 31st, 2013.
A...More
Wednesday, March 27, 2013
Is R&D the Next Sacrificial Lamb?
By Alan Connor
Medical Products Outsourcing (MPO) magazine recently published an editorial entitled “Is R&D the Next Sacrificial Lamb?” discussing the impact of the 2.3% medical device excise tax on R&D investment by medical device companies. We at Cadence believe that R&D will continue to be of primary importance for our customers. What will likely change, however, is fewer internal resources will be available to conduct this R&D while, at the same time, pressure to reduce...More
Monday, March 04, 2013
“Strategy: An Executive’s Definition”
By Peter Harris
The attached article is a short and sweet articulation of a definition for strategy. Many times I find myself wondering how on earth it is possible for the business illuminati to continue publishing new articles on strategy and competition. At some level, it seems like everything that every need be said about competing and strategy has already been said, and the world is just rinsing and repeating the same themes. The flipside of this obsession with creating new...More
Tuesday, February 19, 2013
Delivering the Right Tools
Alan Connor, President of Cadence, recently contributed to an article in ODT (Orthopedic Design & Technology) Magazine. The article, “Delivering the Right Tools”, discusses the demands OEMs have when they turn to partners to create the next-generation device. Among the criteria is the need for smaller, more complex and disposable instruments, all while lowering the cost. Connor discusses how expanded capabilities at Cadence helps to minimize customers' supplier management overhead...More
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