Lambda Medica, LLC
"Solutions Beyond Expectations"
Lambda Medica PR
Solutions Beyond Expectations
Services We Provide:
Business start up planning
Marketing strategies
Financial Analysis
Staff training and management
Office Design
New O.D. mentoring and coaching
Lambda Medica, LLC assists medical device companies from around the world seeking "FDA approval" to sell their products in the United States. One of the first steps for companies who manufacture medical devices is to file a Premarket Notification with the Food and Drug Administration, also known as an FDA 510(k) submission.
In general, manufacturers introducing Class 2 medical devices to the US must submit a FDA 510(k). A similar predicate device that is already cleared by the FDA must be identified. A 510(k) is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device in such a way that it may significantly affect its safety or effectiveness.
Services We Provide:
510K Preparation and Submission
Manufacturer Device Establishment Registration
Device Listing
USA FDA Agent (Manufacturer Representative)