Because of the increasing number of regulations and need for operational transparency, organisations are adopting the use of harmonized and consolidated sets of compliance control. Using this approach, your business can be sure that all necessary governance requirements can be met without spending money on unnecessary duplication of effort and activity from resources.
There’s a complicated and unclear pathway from design to commercialization for a new medical device or IVD. With regulations and requirements varying by country, level of risk, specific product claims and intended use, it is hard to get through this process. The regulatory experts of Grant Thornton can help you gain a deep understanding of the applicable regulations and requirements. We have knowledge that goes further that published guidance documents and other materials.
Our purpose is to design and implement a competitive and cost-effective regulatory strategy, we will also help you preparing and submitting a “reviewer-friendly” marketing application, and serve as your liaison through the process. We will assist you with your negotiation with FDA, EU and other international regulatory agencies.