Each order is approached individually, with attention to compliance with current
legislation, European and Polish standards as well as knowledge in the field. Full confidentiality of the transferred data and research results: this is our guiding principle.
ACC Chemicals deals with complex service in field of implementation of medical product to the market.</br> To ensure consumers safety before implementation of medical product for first time to the market or use it need to be reported and registered. We prepare necessary documentation to register products, furthermore we conduct entire process in Office of Registration Medical Products and Biocidal Products.</br> First stage of work is assessment if product fulfil definition of medical product, next stage is classification of product which defines procedures of compliance assessment, to demonstrate that product fulfil basic requirements.</br> We prepare clinical assessment based on literature review, medical publications, proceeded tests or experience and qualified assessment authors.</br> We offer help in field of design of package, label, instructions and CE marking on products. We verify correctness of content and graphical symbols.</br> We cooperate closely with notified TÜV Nord Poland unit , which certify medical products on criteria of compliance with 93/42/EEC Directive requirements known also as MDD.</br> We provide reliable care and oversight on implemented projects.</br>