To be allowed to manufacture and commercialize medical devices, a manufacturer needs to implement a Quality Management System according to the ISO13485 standard. It is fairly easy to get lost in the documentation.
Do you need some guidance in preparing for the certification? QbD developed a checklist holding a clear overview of all mandatory documentation according to the ISO13485:2016 standard.
For further help with receiving the ISO13485 certification you can contact QbD. We have the expertise to support you in this process.