QM System for sterile medical devices
For a manufacturer of sterile medical products, EXCO creates a customized QM system according to 13485 and establishes the system within the customer organization.
EXCO was commissioned to manage the following tasks:
- Assessment of existing quality management documentation
- gap analysis
- Planning of measures to close the gaps
- Implementation of the measures and creation of a completely new QM system according to EN ISO 13485: 2016
EXCO created a completely new and tailor-made QM system in accordance with EN ISO 13485: 2016, including the entire technical documentation for several products. EXCO also supported the start-up company in the approval process by supporting the submission of the required documents to the notified body.
- Compliant, tailor-made QM system in accordance with EN ISO 13485: 2016
- technical documentation for several sterile products
- Support of the company in submitting the documentation to the notified body
Manufacturer of sterile medical devices, Germany