Made Consulting has recently completed a project with medical device class III product. Our company was responsible for the whole preclinical safety assessment including all safety testing and preclinical documentation to a notify body (Biocompatibility Report).
The documentation was accepted without any supplementary questions by one of the best notify body in EU region. Client was very satisfied the work of Made Consulting because all preclinical issues were covered in the first step and all safety aspects were noticed. No further safety testing was needed to get the product (medical device) on the market. This is a good example how important it is to take the right steps at the beginning of the safety program.