Question
This 2016 article says the first causes the second: http://bit.ly/device-recall-epidemicIt blamed manufacturer risk management for a 2014 peak in recalls: The culture, the shallow industry-wide understanding, the inability to tie risk management into...
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Viky Gilles Daniel Verna
Co-Founder and VP at confinis Corp (US) - Senior Consultant at confinis ag and med-HF (Switzerland)
June 2017
Has anyone experienced an FDA 510(k) pre-clearance inspection? If yes, how long after the 510(k) submission was the inspection performed? Is the firm domestic or foreign? Did they review the DHF of the product under 510(k) review to ensure compliance...
Mike Drues is one of the most gifted regulatory people I know. At 10x he said, If you're going to change a medical device in an administrative way, you have two options to handle that. β’ You notify the FDA (and if you do, how?); or, β’ You don't notif...
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Former $MELA CEO Dr. Joseph Gulfo's book "Innovation Breakdown" is so enlightening (and well-written) that I invited him to join the 10x faculty in May. Was his experience extreme, biased, or common? BACKGROUND β’ Each year, 150,000+ Americans are dia...
Last week I received this question specifically about 510(k) reviews, but I expanded the question to address both types of submissions.The most important thing is to be aware of the review process for submissions and understand the chain of command. ...
FDA has an agreement with EPA where low-level disinfectants used in areas like hospital rooms are regulated by EPA. A client has a low-level EPA-approved disinfectant cleared to inhibit microbial growth on the surface to which it is applied. But rece...
I work for a class II medical device manufacturer that has never done anytime of marketing. My job is to get us into the 21st century with aligning us with the way buyers want to educate themselves and buy - which is digital marketing strategies. How...
I've been hosting 10x Medical Device Conferences for six years but no one β before Bob Marshall β sang on stage. You likely recognize Bob's name if you subscribe to his extremely popular Med Device Online site where he serves as Editor in Chief. I ci...