Quality assurance

The production of medical devices as well as In Vitro Diagnostic products requires a high formal level of quality. The European regulations are governed by different directives from the European Council and are then issued as regulations in Sweden by the Medical Products Agency (MPA).

To be able to ensure the highest possible quality BioHospital AB has already from the start of the company been working with a Quality Management System and was certified according to ISO 9002 back in 1995. Currently we hold a certificate according to SS-EN ISO 13485:2016, Production of medical devices, issued by AAA Certification AB.