"Managing the FDA Maze is decent. 0873894553 ISBN
Use the FDAs own Guid to Inspection of Quality Systems (QSIT). You can work backwards and anticipate what they might ask. Put yourself in the auditors shoes and find the holes in your own…"
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Neil S. Rothman, Ph.D.
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blahblah replied to Neil S. Rothman, Ph.D.'s discussion Regulatory Burden in the group Medical Devices
Jack DePasquale replied to Neil S. Rothman, Ph.D.'s discussion Regulatory Burden in the group Medical Devices"I have just joined a company that will begin to manufacture medical devices. In the past this organization had only been producing components. As part of this step toward device manufacture i will be required to produce Validation Protocols for the…"
mariem myers replied to Neil S. Rothman, Ph.D.'s discussion Regulatory Burden in the group Medical Devices"software validation isn't as bad as process validation btu it is still a very intense area. And a lot of the software engineers outhere lack the FDA knowledge to make the process faster. But I guess there is no way around it in this time and…"
David Paribello replied to Neil S. Rothman, Ph.D.'s discussion Regulatory Burden in the group Medical Devices"I know my boss has been working with the FDA and had his Detective Quantum Efficiency device recently approved (<1 year), although I was not apart of the team when that happened. I also know that another company (Integrated Surgical Solutions)…"
Jeff Pagnutti replied to Neil S. Rothman, Ph.D.'s discussion Regulatory Burden in the group Medical Devices"This is an interesting point of discussion. I have no background in medical device applications; however, it has always caught my interest. In my opinion, in vitro diagnostic testing is a healthy step forward, yet again I know very little about the…"
A.Aghajanian left a comment for Neil S. Rothman, Ph.D."I have learned at school about Digital Signal Processing and my master's project had been about 2D medical image compression. Now, I would like to focus on learning digital image processing to change my career toward that direction but I am not…"
"Sorry, it isn't. I may know some people depending on what you need is. A division of the company I work for spun off a division that does image processing."
A.Aghajanian left a comment for Neil S. Rothman, Ph.D."Hello Mr. Rothman,
I was wondering, if digital image processing is as part of your expertise or not.
Thank you,
AA"
"For example, why should software for a passive monitor (EEG for example) be anything more than a moderate level of concern? If someone is going to base a diagnosis on what the monitor says, which really requires their interpretation, why does a…"
R. Hindinger replied to Neil S. Rothman, Ph.D.'s discussion Regulatory Burden in the group Medical Devices"If we're talking 510(k) applications, I've noticed them cracking down on software.
They've added a new guideline in the last few years for any software associated with a device or system, and it adds to the device manufacturer's…"
Regulatory Burden
In my opinion, the FDA seems to be growing more strict in its review of medical device applications. There seems to be a greater level of concern or perception of risk by reviewers that does not meet the "least burdensome" guideline.I'd like to hear other's opinions and experience.See More
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Comment Wall (3 comments)
- At 4:24pm on December 14, 2009,
Bhakti Thakar said… - hello,
This is Bhakti Thakar,
I graduated with my masters in electrical engineering with major as control systems in Dec2008. I worked in the industry for 6+ years before joining my masters.
I am looking for a job in control system design, model based design, modeling/simulation of industrial systems, control algorithm development.
I would request you to join my network on Engineering Exchange and Linkedin to help me expand my professional network which would help for my job search.
Thank you for your time and help.
Bhakti Thakar
- At 7:39pm on June 8, 2009, A.Aghajanian said…
- I have learned at school about Digital Signal Processing and my master's project had been about 2D medical image compression. Now, I would like to focus on learning digital image processing to change my career toward that direction but I am not sure about career opportunities....how fast this technology is growing...how high demand are DSP engineers....how salary rangers are.....I don't want to be hardware DSP design engineer, but the software & analysis side of it....if I want to master in that subject matter, I need to attend some classes at universities and spend a lot of time and effort ....but before doing that need to get little bit information from professional who are involved in that field and then make my final decision.
Thanks a lot,
AA
- At 10:44pm on June 7, 2009, A.Aghajanian said…
- Hello Mr. Rothman,
I was wondering, if digital image processing is as part of your expertise or not.
Thank you,
AA
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