Laboratory standards are important for the highest quality R&D as well as develop and commercialise personalised medicine. Standards such as BARQA or ISO13485 must be implemented to remain in compliance with CE marking. CE marking is a mandatory declaration of conformity by medical device manufacturers within the European Economic Area (EEA). Once the CE marking has been granted the product may be legally be sold in each of the states of the European Economic Area (the 25 EU Member States plus Iceland, Norway, Liechtenstein and Switzerland) and be able to qualify for reimbursement from the local healthcare system. It is important to ensure a laboratory has a high level of regulatory compliance early in a project development. This will help ensure a smooth path to commercialisation and reimbursement.
Permedx and its partners have proven experience in developing laboratory regulatory compliance for personalised and translational medicine. We can ensure the necessary regulatory systems are in place to develop, sell and market your diagnostic tests within the EEA.