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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: CDRH
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The REdI Fall 2016 Conference: Slides and Recordings
on 5 October 2016 | By Kate Keverline
The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) to provide direct, relevant, and helpful...
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510(k) Pop Quiz!
on 10 January 2014 | By Ryan Kasun
How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got right!
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How the FDA handles complaints
on 19 July 2013 | By Ryan Kasun
Complaints from end users to medical device manufacturers are unfortunately a common occurrence. Medical device manufacturers are expected to handle these complaints efficiently and effectively by keeping the end user or patient’s safety in mind. However not a lot of people...
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Medical Devices | Ergonomics Society | Medical Device Industry | Human Factors Standards | Human Error | Fda Perspectives | Industry Guidance | Regulatory Submissions | Usability Engineering | Cdrh | Human Factors Group
HFES Health Care Symposium – What’s New in Human Factors and Usability?
on 20 March 2013 | By Ryan Kasun
Last week I had the opportunity to attend the Human Factors & Ergonomics Society Health Care Symposium. Since I work on medical devices, I mainly went to the presentations in the medical devices track and found them to be very interesting and educational. The opening keynote...
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Medical Device Industry | Taxes | Fda | Medical Device | Public Health | Govenment | Regulatory | 510(K) | Cdrh
Headaches
on 7 February 2013 | By Ryan Kasun
The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My...
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Creating Consistency
on 8 October 2012 | By Ryan Kasun
One major variable med tech companies are faced with today is the unknown of FDA reviewers. It seems like what works for one company doesn’t necessarily work for the rest. And why is this so?
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