Question
source: https://www.linkedin.com/groups/78665/78665-6181477980418695172
Do you think this will accelerate 3D Printing development? GE Plans to Invest $1.4B to Acquire Additive Manufacturing Companies Arcam and SLM; Accelerates Efforts in Important Digital Industrial SpaceBOSTON, MA (USA) – September 6, 2016 – GE (NYSE: G...
The most important document in a Design History File (DHF) should also be the first document you create when you are developing a new medical device--the design plan. However, I find a number of companies that are preparing to submit regulatory submi...
I suspect the end of Obamacare (how will that unravel?) and the medical device tax going away. What do you foresee? Peg Graham Improving the Caregiving Experience, Chair of the YANA Health Forum Also becoming clear that there will be a major challeng...
How would you describe the medtech job market where you live? Is it easier to find and retain good employees? Harder to find a job? The MD+DI article at http://medgroup.biz/2016-hiring suggests it depends on your functional role and level of expertis...
All Class II devices marketed in the USA must be labeled with UDI bar codes by September 24, 2016--just 19 days away. This announcement summarizes the basic steps for UDI implementation.Step 1: Make a list of all the devices requiring a UDI. A separa...
Group member Tim Hopper wrote me yesterday with tragic news. His son, 19-year-old Ryley, dove head first into a pool and broke his neck at C6. They almost lost him. Ryley is now recuperating at The Shepherd Center in Atlanta, paralyzed from the chest...
Shanshan (Samantha) Chen (ASQ CQA)
RA/QA professional in Medical devices industry, seeking to new opportunity.
August 2016
Do anybody know that is there any labelling requirement for medical device’s Wi-Fi function in Canada? I check the label regulation and they did not mention Wi-Fi, thanks!source: https://www.linkedin.com/groups/2070960/2070960-6176002121310175232
Tejas Yarashi
Orthopaedic Surgical Trainee, Clinical Entrepreneurship Fellow - NHS Innovations, Founder of a Healthcare Startup
August 2016
Hi guys, I'm an Orthopaedic surgical trainee based in London and I have developed an Orthopaedic instrument with an instrument development company who have CE marked it. I really want to get this product into market as it had received a lot of positi...
Even before the FDA’s final rule was published for UDI in 2013, companies were implementing UDI systems. What has not been clear is how the FDA would enforce UDI compliance. The most logical methods of enforcing UDI compliance are:1. require a draft ...
