Quality & Recall Information

We are 100 % committed to the quality and safety in our processes, products and services that we provide to you. To ensure a continuous focus on quality and safety, we embed our quality system in NEN-EN-ISO 9001:2015 and NEN-EN-ISO 13485:2016 certifications.

Additionally we support on quality and security by providing education, protocolling and the correct use of products.

ISO-certificaat 9001:2015
International standard for quality management.

ISO-certificaat 13485:2016
International standard for quality management of medical devices.

ISO-certificaat 14001:2015
International standard for environmentsl management.

Recall

In the event of a product recall by a manufacturer we have appropriate procedures in place:

Types of recalls:
- Medical Device Recall
- Safety Information / important safety warning
- Internal Safety Field Communication
- Urgent information on returning Medical Materials
- ‘Orange Hand Envelopes’ (in case of a pharmaceutical product)

Immediately after receipt of the recall information by Mediq Medeco the following procedure is activated:
- Blockage of the concerning lot number of current stock levels.  
- Informing authorities concerned, in line with Meddev 2.12-1, in case this is not done by a manufacturer.

- Informing all people and customers involved.
- Activating the return process by our Customer Service department.
- Registration of the returned products.
- Producing credit notes for all returned products.

Recalls are discussed by the management team and all authorities concerned