European medical devices approval

See all our services regulatory consulting and registration of medical devices .

Emergo Group is a consultant serving the FDA regulation of medical device companies around the world seeking the approval of the Food and Drug Administration (FDA) to sell their products in the United States. For companies producing medical devices class II (and a small number of those in class I), one of the first steps is to submit a premarket notification, often referred to as 510 (k), with the Food and Drug Administration.

Contact Emergo Group for more information on FDA 510 (k) approval

Technically, when the 510 (k) process prior notification to the placing on the market, the FDA does not "approve" medical devices for sale, it gives them permission to be marketed. As FDA 510 (k) consultants, we use the term "FDA approval" or FDA approval, for simplicity. For marketing approval from the FDA, the first step is the identification of one (or more) predicate device, which is already FDA approved device which is similar to that for which you are seeking permission .

As a consulting firm specializing in medical devices FDA, we prepared and submitted successful applications 510 (k) FDA for medical device companies and IVD worldwide.

Step by step overview of the Enabling 510 (k) process for medical devices FDA.

Who must submit a notification to the placing on the market, known as 510 (k) FDA?

In general, manufacturers introducing class II medical devices in the United States must submit a 510 (k) to the FDA. A 510 (k) is also required for manufacturers altering the intended use of their medical device technology or modifying an already approved device such that the safety or efficacy of the product may be affected.

Step 1: Consulting for the preparation and analysis of pre-gaps 510 (k)

To ensure the success of the 510 (k), Emergo Group, your FDA consultant to obtain FDA 510 (k), takes a two-step approach. We found that this approach is more economical for our customers, while actually increasing the likelihood of acceptance of the 510 (k). The steps of our approach in consulting 510 (k) FDA are listed below.

Directory of the European Medical Device & Biomaterials Industry
Book (Elsevier Science Pub Co)
2005-04-04 22:03:48 by -

Not a lap band survivor here, but

It still has a lot of dangers and complications. Here's an online article (5 years old):
FDA panel refuses to endorse obesity 'Lap-Band'
device
The Lap-Band device
June 19, 2000
Web posted at: 8:45 PM EDT (0045 GMT)
WASHINGTON (CNN) -- A government advisory committee refused to give its seal of approval Monday to a weight-control device that's been used in Europe for seven years - - but has run into medical difficulties during its U.S. trials.
By a 6-4 vote, the Food and Drug Administration advisory committee concluded there was insufficient data to determine whether the device, called Lap-Band, was safe and effective

2003-10-02 06:38:37 by apathetichuman

Sorry for the delay

Had to sleep. Okay, not what you asked for, but, along the same lines. I will find the cream connection and post it later. These articles are all about the companies that pay lots of money for foreskin harvesting. Granted, some of their discoveries are for the betterment of medicine. However, they are all motivated by foreskin for money.
Don't believe it ? Read for yourself - directly from the companies involved - all about the massive foreskin-for-sale industry !
Periscope: Bionic Band-Aid
Newsweek Wednesday, January 13, 1999
Living Human Skin Equivalent Apligraf
Molecule of the Month February 1998
Bioengineered skin wins approval from the FDA
Wound Care newsletter July 1998
The Role of Tissue Engineering in Wound Care
AVF Newsletter American Venous...

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