Founder and CEO of Menlo Park Associates and Menlo Park Software
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...
Viky Gilles Daniel Verna
Co-Founder and VP at confinis Corp (US) - Senior Consultant at confinis ag and med-HF (Switzerland)
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. • You notify the FDA (and if you do, how?); or, • You don't notif...
As originally asked by
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 • Each year, 150,000+ Americans are dia...
Ship & Print Your FDA eCopy
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. ...
*This is not professional advice.* In fact, it's borderline irresponsible, but here goes. So I was talking to this guy who found me from the group. To protect his anonymity, I'll be vague about his selling proposition. He told me he's building an app...
I've been hosting 10x Medical Device Conferences for six years but no one – before Bob Marshall – 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...
Long-time readers won't be surprised that my dear friend, regulatory expert Robert Packard is offering to teach an FDA pre-submission workshop for free. In fact, the last time we held this workshop – some 3½ years ago – more than 1,500 members regist...
Head of Quality and Regulatory Affairs
Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.