Question
The Early-Bird Discount to the 10x Medical Device Conference ends Friday. See http://medgroup.biz/10x-discounts _____ There's no denying you need help if your arm is broken. But what if your spirit is broken? Or you often feel anxious? Or have post-t...
If you manufacture Class III medical devices, you've got a panic-inducing 71 days to comply with Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) guidelines. Are you ready? http://medgroup.biz/UDI-goes-in-ef...
I am interested in hearing from individuals/companies regarding the potential development of a medium term project to develop a universal surgical ostomy port strengthening the abdominal wall. Thank you in advance for your enquiries.source: https://w...
At this year's 10x Medical Device Conference, Seth Goldenberg Ph.D., Senior Principal Scientist at NAMSA, gave an illustrative talk entitled, "Thinking Globally During Medical Device Development: Accelerating Products to International Markets." The f...
When you began your medical device company, you had an idea – and maybe a prototype, funding, and some customer interest. At what point did you start implementing a quality system? It's required to generate the product documentation for regulatory ap...
Have you heard the expression, "I don't know what I don't know?" I was talking with group members Matts Bell and Mike Coon. Both are in business development. Matts Bell works for Argos Global, a complaint handling company. He said, "In 2013, 75 perce...
There are a few such products on the UK market that (from the CE mark and Notified Body number) are Class II devices. They are for sensitive teeth and I can almost understand how they could be pharmaceutical products since they have an active and spe...
At Qmed/MPMN, we've noticed that stories about serious recalls garner a lot of Web traffic from our device designer and engineer subscribers. Maybe it is the same type of psychology that causes people to run down the street to check out a burning hou...
José Ramón Alonso DomÃnguez
Incubation Manager Healthcare - Konica Minolta Business Solutions Europe
February 2014
Hi everyone, I would like to discover good ideas to make the intended user aware of forseeable misuses of a Medical Device, besides User's Guide that from my experience doesn't really work as expected.Trainings would be an alternative but... what hap...
I'd like to know what are your thoughts on the issue? How do you handle the cyber security issue in your company? Do you think we are doing enough to protect medical devices from cyber threats? Did you have to open NCR or seen any adverse event due t...
