Question
Anyone purchased medical devices from China? What is your opinion and sugestion? Thanks.source: https://www.linkedin.com/groups/78665/78665-6162349654370512899
EU representative for CE marking: is Israel consider an European address in your point of view?source: https://www.linkedin.com/groups/78665/78665-6161602791837044737
A client of mine recently asked me to help them plan a clinical study for a low-risk medical device. The company is located in the USA and they intend to launch the product is the USA first. At first I was shocked, because there was no clinical study...
Hello All,I came across situation where I am not sure what is optimal and really required. We have received IEC 60601-2-47 (ambulatory ECG recorder) and IEC 60601-1-2 (EMC) test reports from one of the well known testlabs. Now, Testlab has included c...
Jane Desrochers
Enthusiastic biomedical research engineer with expertise in tissue mechanics, medical imaging and engineering design
July 2016
I'm looking to change career direction into medical device design from academia and notice that so many job postings are for regulatory and quality assurance positions. Direct experience would be best, but if that's not realistic at the moment I'm cu...
source: https://www.linkedin.com/groups/78665/78665-6160856893351874560
Hello everyone. I am looking for a medical device to measure trans-diaphragmatic pressure. We know this can be done by combining the measurements of abdominal pressure measured with a gastric catheter, and pleural pressure, as assessed with an esopha...
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If you had to give someone designing a medical device just one tip, what would it be?As a marketeer mine would be: 'Start with the customer and work backwards.'Note: I'm hoping to use some of these comments in an article I'm writing, full credit will...
Life science companies have paid multi-billion-dollar fines resulting from non-compliant promotion. FDA requires companies to have a system in place to ensure that their promotions meet FDA expectations. Big device companies have an internal Promotio...
