510(k) pre-market notification

A 510(k) premarket submissions is needed to demonstrate the safety of a medical device ahead of marketing in America and Canada. The submission must include a comparison to a similar device that is already on the market, and highlight the differences. Our team at Cranage Veritas are able to assist with your testing and documentation for your medical device, ahead of marketing in the USA. We have experience assisting clients throughout the UK 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.

Get in touch with our expert team to discuss how we can help you with your 510(k) submission

For more information on 510(k) pre-market notification talk to Cranage Veritas