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india, labeling, medical device industry, medical device, compliance, regulatory, registration

India Medical Device Labeling

This week I will provide some information about labeling in India. CDSCO..


Medical Devices, medical device industry, FDA, K97-1, Guidance Document, regulatory, 510(k)

FDA 510(k) Memorandum #K97-1 “Deciding When to ...

The FDA is looking for industry input for the revision of FDA 510(k) Memorandum..

Medical Devices, medical device development, March Madness, medical device industry, Innovation

March Madness

The season is upon us. Unfortunately, the season is not spring…winter still..

quality agreement, 21 cfr, supplier selection, medical device industry, FDA, supplier management, supplier quality

Getting Control of Supplier Controls

It seems that for one reason or another supplier controls are a requirement..

Da Vinci, medical device industry, technology, medical device, technology advancements, surgery system, Robot-assisted, Intuitive

Technology Overkill?

Over the past few years, there have been some really great technologies that..

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..