ISO 13485 "Medical Devices: Quality Management Systems - Requirements for Regulatory Purposes"
We have been ISO 13485 certified since 2023, here you can find the current certificate.
Again, these excerpts from the 2023-08-10 audit report for ISO 13485 provide you a little more information (email me if you would like a copy of the entire report):
- Chapter: Reporting
- "The Solcept process documentation is very detailed, which is appreciated by the employees. Process reliability is correspondingly high."
- Chapter: Conformity and Effectiveness of the Management System
- "The management system is very detailed and is constantly being expanded."
- Chapter: Management Accountability
- "Overall, it is possible to speak of a very deliberate and well-managed strategy and leadership style of the management team."
- "During the audit, the working atmosphere appeared very good and also a high level of personal responsibility for one's own work and a high level of loyalty of the employees to the organization could be recognized."
- Chapter: Positive Impressions from the Audit
- "Transparency and exemplary control of documents."
- "The customer-oriented (customer-related) cooperation of the company."