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.


Tasks

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

Implementation

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.


Client benefits
  • 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

Client

Manufacturer of sterile medical devices, Germany

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Jörg Petrullat

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