Certificates
Certificates for Von Ardenne Iratherm 1000 WBH wIRA Hyperthermia Devices
The von Ardenne Iratherm 1000 Whole Body Hyperthermia WBH wIRA device has undergone rigorous testing and received comprehensive certifications to comply with international and local standards and regulations, ensuring its safety, quality, and efficacy for integrative cancer treatment
Detailed Certificates of von Ardenne Iratherm 1000 WBH wIRA Hyperthermia Device
UNI CEI EN ISO 13485 Quality Certification for Medical Devices
The von Ardenne Iratherm 1000 WBH wIRA hyperthermia device proudly holds the UNI EN ISO 13485 quality system certification.
The certificate confirms that Von Ardenne Institut für Angewandte Medizinische Forschung GmbH has implemented and maintains a Quality Management System (QMS) that meets the requirements of DIN EN ISO 13485:2021-12 (ISO 13485:2016).
ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
For von Ardenne Institute this certification underscores our commitment to meticulous quality control throughout the entire lifecycle of the Iratherm 1000 WBH wIRA hyperthermia device, from design and development to production, installation, and servicing. It is a fundamental assurance of our dedication to patient safety and product excellence, establishing a robust framework for our operational processes.
Key Points of Relevance:
- Certified Company: The certificate was issued to Von Ardenne Institut für Angewandte Medizinische Forschung GmbH located in Dresden, Germany.
- Standard Achieved: The company has been certified by SLG Prüf- und Zertifizierungs GmbH as conforming to the ISO 13485
- Scope of Certification: The QMS covers the Manufacture, production, maintenance, and distribution of whole-body hyperthermia systems, as well as the maintenance and trading of oxygen concentrators and accessories.
- Validity: The certificate is valid from 2025-08-29 until 2028-08-28.
In summary, this certificate is highly relevant as it demonstrates the company’s commitment to quality and safety in the medical device field, particularly for their whole-body hyperthermia systems. This compliance is critical for regulatory purposes and for building confidence among customers and healthcare providers.
CE- EU Declaration of Conformity (IRATHERM 1000M)
The EU Declaration of Conformity (DoC) for a medical device. This is a critical legal document where the manufacturer, Von Ardenne Institut für Angewandte Medizinische Forschung GmbH, takes sole responsibility for ensuring that the product meets all applicable European Union (EU) regulations.
Key Points of Relevance:
- Legal Compliance and CE Mark: The DoC is the legal prerequisite for applying the CE mark to the product, which is mandatory for placing a medical device on the EU market. By signing it, the manufacturer certifies that the device complies with:
- Directive 93/42/EEC (Medical Devices Directive).
- Directive 2011/65/EU (RoHS Directive), concerning the restriction of hazardous substances.
- Certified Product: The declaration specifically covers the Whole-body hyperthermia system, identified as Type IRATHERM 1000M.
- Intended Purpose: The device is intended for mild and moderate whole-body hyperthermia using infrared A radiation.
- Classification: The device is classified as Class IIa (per Annex IX Rule 9 of Directive 93/42/EEC).
- Devices in Class IIa are considered to have a low to medium risk and require the involvement of a Notified Body (an independent third-party organization) for conformity assessment.
- Notified Body Involvement: The conformity procedure involved the Notified Body SLG Prüf- und Zertifizierungs GmbH (CE 0494).
- Validity: The declaration applies to all listed models produced on or after 2025-08-29 and is valid in connection with the specific EC Certificate 25-P-Schu-0036 (109963N5) until 2026-09-30.
- Traceability and Standards: It confirms the use of various applicable standards (like EN ISO 13485:2021) and includes unique identifiers (SRN: DE-MF-000011313 and EUDAMED-DI: B-DEMF000011313000005218H) for tracking the manufacturer and the device in EU databases.
In essence, the EU Declaration of Conformity is the manufacturer’s formal promise that the IRATHERM 1000M is safe and performs as intended, adhering to all European health and safety requirements for medical devices.
This letter is a key document for ensuring the device’s continued market presence under the transition to the new Medical Device Regulation (MDR, EU 2017/745).
- MDR Transition Status: The Notified Body (NB 0494, SLG Prüf- und Zertifizierungs GmbH) confirms that the manufacturer has submitted a formal application and signed a written agreement under the MDR.
- Extended Validity: This confirmation letter is crucial because it allows the IRATHERM®1000M, an MDD-certified device, to benefit from the extended transition periods established by Regulation (EU) 2023/607.
- MDR Compliance Deadline: The deadline for this Class IIa device to fully comply and be certified under the new MDR is 31 December 2028.
- Surveillance: The NB confirms it is responsible for the appropriate surveillance of the device under the applicable Directive during this transition period.
- Validity: The letter itself is valid until 30 September 2026.
In summary, the documents confirm that the IRATHERM 1000 is a legally compliant Class IIa medical device in the EU and that the manufacturer is actively progressing its certification toward the new, stricter MDR requirements, securing its market access until the end of 2028
