Question
We are not going for FDA compliance. We do however have a lot of ASTM, FCC and such certifications, not UL though.A doctor is asking for certification that our product won't hurt the baby (rashes, electric burns, etc). How do we certify this?source: ...
Maurizio Vecchione supports Bill Gates’ efforts to invent and deploy technologies specifically focused on improving life in developing countries. He is the senior executive of Global Good, a collaboration between Bill Gates and Intellectual Ventures ...
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...
The new Apple Watch has native and third party apps that help improve medication adherence, motivate people to exercise, monitor heart rate, monitor blood glucose, and more. With all these health apps and many more under development it seems that the...
How'd you like to have one audit instead of four? In an effort to accelerate international medical device regulatory harmonization and convergence, the International Medical Device Regulators Forum (IMDRF) developed common standards for quality manag...
I am presenting at OMTEC 2015 on Design for Manufacturability and I am looking for some insite.http://rltindustries.com/technical-seminar-design-manufacturability/Technical Seminar: Design for Manufacturability -OMTEC 2015 for Design for Manufacturab...
A few months back at a medical device investor conference, an Intellectual Property (IP) lawyer basically said: If a LARGE company steals a SMALL company's IP – and SMALL sues – SMALL will lose most of the time because it doesn't have deep pockets, b...
Do you manufacture your medical devices in India? Would you? In late December, the Indian government allowed 100 percent Foreign Direct Investment (FDI) under automatic route for medical devices to encourage investors to manufacture in the country. F...
A Bank of America analyst called it the "Death of the Device Salesman." He was talking about a 2013 Wright Medical Group strategy to dramatically reduce hip and knee prices with a "no-frills" option that excluded logistical support or onsite technici...
Mark Armstrong, MD, MSBE
Associate Medical Director for Colorectal Health and PACE Curriculum Manager at Medtronic
March 2015
Preliminary studies used nanoparticles targeting arterial wall damage. Once at the damaged site, the particles released the protein annexin A1. Researchers had a 70% targeting rate and reported signs of vessel healing after the therapy.Precision nano...
