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The quality of a medical device has a direct impact on the efficacy of the device and the safety of patients, users and others. Therefore, manufacturers and suppliers of medical devices have to provide proof of safety and effectivity.
MedTec Medizintechnik GmbH is a certified manufacturer in accordance with DIN EN ISO 13485 by TÜV SÜD Produktservice GmbH. This guarantees highest standards of quality in development, production and final inspection of every MBST therapy device and every single MBST therapy card.
The standard DIN EN ISO 13485 “Medical devices: Quality Management Systems – Requirements for Regulatory Purposes” deals with the requirements that manufacturers and suppliers of medical devices have to meet when developing, implementing and maintaining management systems in the medical device industry. This is intended to ensure compliance with the regulatory requirements through effective implemented processes. This is tested in annual audits at the company’s headquarters by TÜV SÜD as an independent notified body.
MBST therapy devices are approved medical devices in accordance with EU regulations MDR. While the deadlines for the final implementation of this relatively new medical device regulation are postponed again and again because many manufacturers have not yet proven compliance with the new, distinctively stricter requirements, MedTec was able to achieve certification in accordance with MDR standards already in 2023.
MedTec Medizintechnik GmbH relies on TÜV SÜD Product Service as notified body, which was designated by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) as one of the first Notified Bodies worldwide for the new Medical Devices Regulation (MDR). A strong certification partner creates trust among patients, users and staff.
Within the scope of MDR certification, manufacturers of medical devices must submit complete clinical evidence. The clinical evaluation report for MBST magnetic resonance technology regarding its safety and therapeutic potential and proof of clinical efficacy is updated annually to include new results from studies and research.
It also includes a product registry that is validated by an independent service provider which collects data from the clinical application in medical centers with scoresheets.
As required, all MBST magnetic resonance therapy systems only use REACH-compliant materials. REACH is a directive of the European Union that was issued in order to further the protection of human health and environment from the risks of chemicals. In principle, REACH applies to all chemicals, not only those used in industrial processes, but also those of daily life such as cleaning products, paints as well as clothing, furniture and electrical appliances. The regulation therefore has an impact on most businesses in the EU.
All components of our medical devices that come into contact with patients or operators are made with REACH-compliant material. MedTec Medizintechnik thus completely fulfills REACH requirements.
REACH’s objective is the regulation of substances of very high concern. Such substances must pass an approval process, are listed in a so-called “candidate list” and the information must be communicated if a product contains one of those substances in a concentration of more than 0.1% by mass. The safety and well-being of patients are one of MedTec’s top priorities. Therefore, our MBST magnetic resonance therapy devices do not contain any substance that is listed on the candidate list, neither now or in future.
This is connected with the requirements of biocompatibility. All materials that come into direct contact with the human body must not cause unwanted side effects for the patient and still be able to fulfil their function.
The materials used in a medical device must not cause any harm to the human body. Any detachment of particles that may occur must not cause any reactions such as inflammation. On general: “A medical device must not cause any damage to the patient.”
Our MBST therapy devices are not only easy to handle and to clean and visually appealing. They also only use biocompatible, harmless materials for any kind of surfaces that come into contact with patients.
All MBST magnetic resonance therapy systems carry the CE marking. This demonstrates that our MBST devices are completely compliant with legal regulations.
The CE marking ensures that risks and side effects are analysed, assessed and reduced. The biocompatibility is guaranteed and risks of infection are reduced or eliminated. Mechanical, electrical and electromagnetic safety is ensured and the instructions for use are checked for completeness and comprehensibility. In addition, the medical devices are clinically or diagnostically assessed to make sure that the stated product characteristics and specifications regarding therapeutic or diagnostic benefit are met. Both the manufacturer and the medical device are monitored during the entire product life cycle.
The CE-marking confirms: MBST devices are safe, effective and effectual.
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