DIN EN ISO 13485
The requirements for the quality of medical devices are specified in EN ISO 13485. NAWA Heilmittel GmbH’s quality management system is based on these standards.
Medical device guideline 93/42/EWG, appendix II
The EC Directive for Medical Devices and the Medical Devices Act in Germany lay down basic requirements for medical devices. A distinction is made between four risk classes (I, IIa, IIb and III) to which a medical device must be assigned. All NAWA Heilmittel GmbH products are classified accordingly.