I've been seeing the word graphene show up again and again as a wonder material for medical devices. I found http://bit.ly/12-graphene-uses online and it happened to be written by my friends at StarFish Medical in Vancouver, Canada. For today's discu...
Dear all, I have a question about RUO and IUO labeling in US market.According to FDA guidance "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only": RUO product is an IVD product that is in the labor...
Adam Malofsky, PhD
Managing Partner, Elemence - We Help, Listen & Learn - $2.5+B Innovation/yr - Collaborator, Innovator, Advisor, Speaker
Will graphene meet the same fate as superconducting materials?Scientists are racing to patent and profit from a new material, graphene, also called the “wonder material” of the nanomaterial universe. It is 100 times stronger than steel but as thin as...
Ship & Print Your FDA eCopy
Global medical device and life sciences product labeling is a complex subject and an integral part of the supply chain. The landscape is varied in terms of the systems and processes employed in designing, populating and printing labels (including boo...
Group member Mike Tipton sent in this question: I'm working with a start up company. One of our investors asked what are the biggest threats to the medical device space in the short term, and how can you best mitigate that risk? How would you answer?...
Consider the following: device OEM is in Germany, contract sterilisation is done in the UK, the OBL owner (and therefore Legal Manufacturer) is also in the UK. For labeling in the US market, which is the correct country of origin: Germany or the UK?s...
There were 274 companies listed under "Wearables" at the Consumer Electronics Show last month. 237 under "Health and Biotech." 87 under "Biometrics." That's at the CONSUMER Electronics Show. See http://medgroup.biz/device-design for access to our fre...
As originally asked by Brian Biersach. In the past year, I’ve seen something that I haven’t seen in my whole career of medical device compliance work. Devices that don’t work (software and hardware problems), serious compliance issues with performanc...
CEO/Founder, Cambridge Research & Development
As originally asked by