Regulatory services

We assist you with your certification

Alcis’s regulatory department puts its expertise at your disposal: several decades of constantly-fuelled experience in the field of medical device certification as well as in implementation and improvement of quality management systems.

Our engineers and technicians are specialized in the medical device field and are experts in the aspects specific to each medical device class in various markets such as Europe, China or Brazil. We contribute to putting various devices on the market for very different fields of application.  Our strength is that we are a legal manufacturer ourselves for different medical devices from class I to III which are sold in France and abroad, and we put this field experience at the service of your products, in the context of growing regulatory challenges. 

Alcis assists you through your development or growth and helps you to face changes in the regulatory framework of medical devices. We can help you to validate a cleaning, packaging or sterilization process.