Question
The American Cancer Society today said women need fewer mammograms starting later in life, which is counter to what other groups recommend.Especially if you're in the oncology, diagnostic, or mammogram businesses, what's your take on it? source: http...
Today we are discussing medical device manufacturers' corrective and preventive action (CAPA) processes. First, so we're all on the same page, visit http://medgroup.biz/CAPA for free resources from MasterControl. The http://medgroup.biz/CAPA link giv...
source: https://www.linkedin.com/groups/78665/78665-6062254003213914114
If you quickly scan through the Federal Register looking for notices that affect either the drug or device industry, you may have missed seeing something important on September 25th. The title of the notice for a proposed rule was âClarification of W...
Tom Nonnemaker
Experienced Project/Program Manager, NPD, Acquisitions, Supply Chain Management, Class I & Class II Medical Devices
October 2015
I'd be curious if anyone is 'in the know' on awareness of any general strategy for compliance to the UDI ruling for non-sterile implantables (such as spinal implants) ? The FDA gave us an extension to Sep 2016 to implement, but there is no real clear...
Since the EN version of ISO 14971 was released in 2012 I have received lots of requests from clients to help address nonconformities from Notified Body auditors. In the past year the frequency of this nonconformity has increased substantially.The FDA...
Flora Sandra Siami
SVP | Corporate Management | Clinical | Regulatory | Quality | Business Development
October 2015
Coverage and reimbursement continue to be major sticking points for getting medical devices into the field.Reimbursement Seen as âOne of the Biggest if not the Biggest Barrierâ to Medical Device Market...Bill Hawkins, the MDIC chairman and a former M...
Adam Malofsky, PhD
Managing Partner, Elemence - We Help, Listen & Learn - $2.5+B Innovation/yr - Collaborator, Innovator, Advisor, Speaker
October 2015
Will graphene meet the same fate as superconducting materials?Scientists are racing to patent and profit from a new material, graphene, also called the âwonder materialâ of the nanomaterial universe. It is 100 times stronger than steel but as thin as...
Given the increasing frequency of infections issues related to reprocessing of duodenoscopes at FDA and the subsequent remedial post market studies they are requiring, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465639.htm?source=gov...
Would the fact that your employer did not have access to the data and paid for the wearable for you and your family make a difference? Gartner projects that by 2018 2 million employees will be required to wear health and fitness tracking devices. Wit...
