Quality management
93/42/EEC
As a manufacturer of medical devices, synedra attaches great importance to the quality of its products and services. We pride ourselves that the entire synedra AIM product portfolio has been certified to the risk class IIb as defined in the European Directive 93/42/EEC, thus fulfilling the EU requirements for medical devices (CE marking). This compliance is assessed at least once a year by an accredited, independent certification authority. To make the quality in product development measurable, synedra applies the following methods:
EN ISO 13485:2003 and EN ISO 9001:2008
Since quality management involves more than the quality of a product, synedra as a company is certified to the international standards EN ISO 9001:2008 and EN ISO 13485:2003. Consequently, we commit ourselves to the following measures:
As a manufacturer of medical devices, synedra attaches great importance to the quality of its products and services. We pride ourselves that the entire synedra AIM product portfolio has been certified to the risk class IIb as defined in the European Directive 93/42/EEC, thus fulfilling the EU requirements for medical devices (CE marking). This compliance is assessed at least once a year by an accredited, independent certification authority. To make the quality in product development measurable, synedra applies the following methods:
- Risk management of all synedra AIM modules according to the FMEA method
- Transparent documentation of all product requirements
- Version management
- Upholding and improving the quality of our software, e.g., by means of a build system, regression tests, CVS, use cases, code reviews...
EN ISO 13485:2003 and EN ISO 9001:2008
Since quality management involves more than the quality of a product, synedra as a company is certified to the international standards EN ISO 9001:2008 and EN ISO 13485:2003. Consequently, we commit ourselves to the following measures:
- Continued training for our employees
- Documentation of workflows and expertise
- Systematic surveys on customer satisfaction
- Control and avoidance of error accumulations
- Company-wide, standardized measurements for constant quality improvement
- Constant re-evaluation of the measures taken
