Why Choose Emergo Group?

Emergo Group has compiled dozens of FDA 510(k) Premarket Notification applications each year. Few consultants have more experience in what it takes to get these applications approved by the FDA. We use this experience to get your Class 2 (II) medical device approved faster and with greater chance of success than might have otherwise been achieved. Getting your medical device approved quickly means you will be able to generate sales faster.

We have completed submissions for a wide variety of medical devices. In addition we have worked with hundreds of other device companies on European Technical File construction and other regulatory issues. Therefore, chances are good that one of our consultants is very familiar with your medical device.
Here are more reasons to consider us for your FDA 510(k) submission:

We are very experienced in preparing 510k applications for Class 2 (II) medical device manufacturers all over the world. Our fees are very competitive for the preparation and submission of FDA 510(k) applications. We can also assist you in meeting the requirements of FDA Good Manufacturing Practices (GMP) or ISO 13845 if needed.

Emergo is an ISO-registered consulting firm with offices throughout the US and Canada plus offices in The Netherlands, China, France, Japan, Mexico and Australia.