Question
As originally asked by
ISO, the International Standards Organization, tells us risk-based changes to the ISO 13485 standard are "to be published by the end of 2015." The new 13485 will build upon principles laid out in ISO 14971, the current risk management standard for me...
I do, and I asked my wife the same thing as we watched "The Immortalists," a documentary about Doctors Bill Andrews and Aubrey de Grey, who want to "live forever or die trying." It was a mind-expanding film. See http://medgroup.biz/the-immortalists P...
Is this going to be solved exclusively with pharmacology or might devices play a role? 3 preparation tips to head off 'explosive' Zika pandemic - FierceHealthcare http://ow.ly/XEl9w Brian Marckx, CFA Director of Research. Senior Equity Research Analy...
This piece from ICON at https://medgroup.biz/mHealth got me thinking about mobile for medical devices. The points that resonated most with me: • mHealth enhances clinical trial recruitment & retention for people who AREN'T mobile; reducing in person ...
Gavin Bogle, an intellectual property lawyer I met at PEDS2040 surprised me when he said, "At this point, diagnostics are really not patentable." I recorded his 5-minute answer at http://medgroup.biz/not-patentable Gavin: Under “The Mayo Clinic v. Pr...
My friend Stephen Carter from Mewburn Ellis gave a 10-minute talk about the European Unitary Patent Package at the 10x Medical Device Conference in May 2016 – before the Brexit vote. His worthwhile summary at http://medgroup.biz/EU-patents (free acce...
As originally asked by Jose Luis Maglione. Hello Group!! I would like to share with you a doubt about how to assess how often a calibration is needed and what international Regulation/Standards should be tested for devices like signal generators, Pat...
In 2014, the Medical Devices Group swelled past a quarter-million members, we hosted the second annual 10x Medical Device Conference, and many of you met in person, talked here, and made valuable business connections. Here are the most popular discus...
Too good not to share from my friend Gunter Wessels http://bit.ly/GunterW His main point: "Appropriateness of care” will guide coverage, payment, and utilization of your devices from now on. MYTH 1: Device tax repeal will happen. We don’t see how the...
