FDA 510(k) Assistance

A 510 (k) is the technical documentation required for those intending to market a medical device in the US. 510(k)’s are usually for Class II medical devices (although also some Class I, and Class III medical devices). A 510 (k) premarket submission demonstrates a medical devices safety and effectiveness for use. In the submission you will need to detail the similarities and differences of your medical device with a similar device that already exists on the market. Our experts have all the knowledge, skills and experience to help make your medical device 510(k) submission as clear and efficient as possible, to reduce the potential for revisions, reducing the total time taken and costs involved. We have experience assisting clients in: Classification of your medical device or equipment Identifying a predicate device Identifying the relevant testing procedures required for your medical device or equipment Assistance in compiling your technical documentation Technical documentation review

For more information on FDA 510(k) Assistance talk to Cranage Veritas