One of the first things we often suggest to our clients is to build a Medical Device Regulatory strategy document. This document essentially becomes the blueprint for how a client will get their product to market.
In this strategy document we outline the medical device regulatory clearance pathway for a particular geographic region and the proposed success strategy including product classification rationale and the associated regulatory submissions required in order to gain marketing clearance in that region. You wouldn't build a house without a blueprint, so why navigate the regulatory landscape without a defined pathway?
After extensive research, RQMIS will identify and define the various options and pathways available for your product. This strategy document will identify quality standards conformance requirements, preclinical testing and clinical study requirements (if applicable), labeling requirements, and quality system requirements such as design control.
We hear it all the time: when clients meet with investors, one of their main topics of concern is the regulatory strategy toward the UK, EU, or the FDA medical device clearance. With RQMIS' help, you can rest assured that you have a clear plan forward, helping to instill confidence in those investors and ultimately get your medical device, pharmaceutical, nutraceutical, or cosmetic product on the market in a way that suits your budget and meets your deadlines.
Let us point you in the right direction. Give us a call today at (978) 358-7307, or just click here: