Why hire Emergo to submit your Class II medical device for FDA 510(k) clearance
Emergo Group has compiled more than 100 FDA 510(k) Premarket Notification applications for since 1997. Few companies 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 more than 100 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:
- Our fees are very competitive and we charge a flat rate fee for the preparation and submission of your 510(k). We provide unlimited phone and email support for the preparation of your 510(k).
- We are very experienced in preparing 510k applications for Class 2 (II) medical device manufacturers all over the world.
- 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 and Australia.
These other services may interest you:
FDA Good Manufacturing Practices GMP Implementation Support
Packaging Waste Directive compliance in Europe
GMP training (Good Manufacturing Practices) for medical device companies
