Quality management

93/42/EEC

As a manufacturer of medical devices, synedra is conscious of its responsibility with regard to the quality of its products and services. To account for this responsibility, the entire synedra AIM product portfolio has been approved as a Class IIb Medical Device as defined in the European Directive 93/42/EEC, thus meeting 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 quality in product development measurable, synedra applies the following methods:

  • Risk management covering all synedra AIM modules according to the FMEA method
  • Transparent documentation of all product requirements
  • Version control
  • Assuring and improving the quality of our software, e.g., by means of a build system, regression tests, use cases, code reviews, ...

 

Downloads

93/42/EEC (PDF file, 436 KB)

EN ISO 13485 & EN ISO 9001

Since quality management involves more than the quality of a product, synedra as a company is certified to the international standards EN ISO 9001:2015 and EN ISO 13485:2016. Consequently, our customers and system partners can rely on synedra committing itself 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

Downloads

Certificates of synedra IT GmbH and subsidiaries

EN ISO 9001:2015 (PDF file, 474 KB)

EN ISO 13485:2016 (PDF file, 728 KB)

 

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