Establishing regulatory documentation and compliance for fluorapatite as a bioactive material

Purpose and goal

The project will ensure that Nano Denticas bioactive fluorapatite (FA) complies with current regulations and thereby accelerate its use in dental products. The goals are to establish validated processes, robust documentation and a lean quality management system in line with MDR and FDA. The project strengthens Nano Denticas´s role as a supplier, supports partners in market introduction and builds internal competence in regulatory issues to reduce dependence on external consultants.

Expected effects and result

Expected results: A regulatory gap analysis with action plan, technical documentation, a limited quality management system with standard procedures and strengthened internal competence. Long-term effects: Faster commercialization via partnerships, increased competitiveness for Swedish medical technology, sustainable growth for Nano Dentica and improved patient safety through safer dental products.

Planned approach and implementation

Nano Dentica will collaborate with Key2Compliance AB in the following areas: conducting a regulatory gap analysis, developing technical documentation and templates, internal training including SOPs, and establishing a limited quality management system in accordance with ISO 13485, MDR and FDA.