Quality and Regulations

Qualitymanagement and
Regulatory Affairs

Radimed GmbH's expertise is characterized by over 25 years of experience in the field of conformity assessment of medical devices.

As a manufacturer of medical devices, Radimed GmbH uses a complete quality management system to comply with legal requirements.
To ensure product quality, the QM system is certified according to the harmonized standard DIN EN ISO 13485 by an accredited certification body.

With the entry into force of the European Medical Device Regulation (MDR), the importance of quality management has increased even further.

Radimed GmbH carries out conformity assessment procedures for medical devices in accordance with Regulation (EU) 2017/745 (MDR), which are certified and monitored by a notified body. All of our products bear a CE mark.

We are currently in the transition phase, so that some of our products have already been successfully certified according to the MDR, while some are still being marketed as legacy devices.

The relevant certificates and declarations can be found in our download area.

If you have any questions, please contact us

Quality

Safe and high-quality products are achieved through monitored production and validated or verified processes.

Complaint

If you are dissatisfied with the products or service or if you encounter any problems, please contact us directly so that we can improve.

QM-System

To continuously improve and monitor our product quality, our QM system includes processes such as:

documentation
Complaints processing
CAPA
Audit
training
Change Control

Traceable

All Radimed products have batch or serial numbers and can be fully traced.

Identifiable

The UDI marking including barcode helps to identify the products quickly and easily.

Safely monitored

Even after the products have been placed on the market, they continue to be monitored continuously by market surveillance.
As a user of our products, take part in our surveys and help us to collect important information about their to receive a rating.
By scanning the QR codes below, you can quickly and easily access the relevant surveys. Completing the questionnaires only takes about 2 minutes.

Quality and Regulations