R&Q Resources

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FDA, CDER, CDRH, Conferences

The REdI Fall 2016 Conference: Slides and Recordings

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum..


FDA, 510(k) review, 510(k), CDRH

510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is..

Ombudsman, CDRH

How the FDA handles complaints

Complaints from end users to medical device manufacturers are unfortunately a..

medical device industry, taxes, FDA, medical device, public health, govenment, regulatory, 510(k), CDRH

Headaches

The FDA received funding to increase its workforce at the CDRH for 2012 and..

medical device review, FDA, medical device, Emergo Group, CDRH

Creating Consistency

One major variable med tech companies are faced with today is the unknown of..