Quality Management

Noviotissue is active in field of tissue banking and biomaterials. The company has set up a Quality Management System that adopts the principles of ISO 13485:2016 and 21CFR 820. Noviotissue complies with Directive 2004/23/EC and is working towards an accreditation as tissue bank establishment.

Tissue portfolio development

By developing new tissue products, Noviotissue uses principles from the Medical Device Regulation as starting point. By setting up a medical device file we can meet any and all regulatory standards now, as well as future standards. By using a risk based approach we identify product risks and these will be mitigated early on. The medical device file is used to set up the manufacturing process and will be transferred upon request.

Processing

Tissue banks need to have a quality management to comply with national laws on tissue banking. Noviotissue will ensure that by setting up new processes or altering processes, we comply with your own quality management system. We also ensure that from the start we keep in mind the requirements for process validation, where we use the principles of ISO 13485:2016.