Develop the optimal regulatory strategy
Regulatory compliance is the overarching term for several activities. What it constitutes is that the manufacturer of medical devices will have duties to comply with regulations, either in US (FDA, 510k), EU (CE), China (CFDA), or other markets. All these regulations have their own specific requirements, although there is a common basic set of essential requirements that is valid for each and every country.
In order to reach or stay in compliance you will need to have a regulatory strategy. We translate medical device regulations to regulatory strategy. Our philosophy is to optimize and customize advice; our practical approach supprots eacht individual company in the most efficient and cost effective manner.