DIN EN ISO 13485 · MDR (EU) 2017/745
Certificates and documentation
Everything procurement, hospital hygiene and public authorities need, in one place, from the DIN EN ISO 13485 certification to product registration.
DQS Med certified
Over 3 million units of own products in stock
Available from stock
Since 2004
Certification
Our quality management system is certified
Rescue Trade™ is certified to DIN EN ISO 13485 by the certification body DQS Medizinprodukte GmbH (DQS Med). The certificate confirms that Rescue Trade™ has implemented and maintains a quality management system that fulfills the requirements of the standard.
The certification covers the company's quality management system, not individual products.
Scope of the certification
Design and development
Manufacturing
Packaging
Warehousing
Distribution of non-sterile medical devices, focusing on medical disposable bedding sets, transfer sheets and transport sheets
Distribution of further non-sterile medical devices
DoC
Declarations of conformity (DoC)
EU declarations of conformity for the three product lines (Class I medical devices) are available here. The DIN EN ISO 13485 certificate confirms the quality management system – not certification of individual medical devices.
Documentation
Registration and classification
BfArM / EUDAMED
The company and its products are registered with the German Federal Institute for Drugs and Medical Devices (BfArM) and in EUDAMED, the European database on medical devices. Procurement departments can verify the registration there themselves.
Class I medical devices
Under Regulation (EU) 2017/745 (MDR), the Rescue Bedding™, Rescue Transfer™ and Rescue Carry™ product lines are classified as Class I medical devices, the class subject to the lowest regulatory requirements. The manufacturer declares conformity under its sole responsibility.
Questions about our certifications?
For tender documents, supplier audits or further documentation, we respond promptly.
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