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Eschmann achieves EU MDR certification for its autoclaves
4th Sep 2024 in Dental, Animal Health, HealthcareEschmann, a leading British manufacturer of decontamination products and provider of first-class support services in the field, has recently received the EU Medical Device Regulation (MDR) certification for the range of autoclaves. This achievement marks a significant milestone in ensuring the highest standards of safety and performance for medical devices within the European Union.
A long-standing commitment to quality and safety
The regulations are in place to promote patient safety, while also increasing transparency regarding the lifecycle of medical devices. Eschmann’s journey to EU MDR certification began with a comprehensive review of their existing processes and products. The organisation has always prioritised quality and safety, and this certification is a testament to their on-going work in the area. By adhering to the stringent requirements of the EU MDR, Eschmann ensures that all their autoclaves meet the highest standards of safety, performance, and reliability. The result for dental professionals is the provision of decontamination products that can be depended on to minimise the risk of infection among staff, patients and practice visitors.
Rigorous testing and validation
Achieving EU MDR certification involved a review of the research and testing that has already contributed to the development of Eschmann’s industry-leading autoclaves. Each device underwent extensive assessment to ensure compliance with the new regulations. This included thorough evaluations of each product design and all associated manufacturing processes, as well as post-market surveillance. Eschmann’s dedication to continuous improvement and innovation played a crucial role in meeting these stringent requirements.
A comprehensive product portfolio
With more than 60 years of experience in designing and manufacturing autoclaves, it's no wonder that Eschmann has become a nationally recognised expert in decontamination. The comprehensive portfolio today includes a range of Little Sister autoclaves, affording different capacities, as well as a combination of vacuum and non-vacuum options, and both ‘B’ and ‘N’ type cycles to accommodate the needs of every dental practice. Designed for reliability, efficiency and durability, the autoclaves are available with a dedicated Little Sister Autolog and e-Logbook, which provide automatic recording of cycle data for convenient compliance. Eschmann also provides an array of other decontamination solutions to complete the infection control workflow in any practice, including washer disinfectors, ultrasonic cleaners and RO water systems.
Exceptional support to match
In addition to industry-leading solutions and EU MDR certified autoclaves, Eschmann delivers peace of mind to customers with exceptional technical support. The Care & Cover servicing and maintenance package gives customers access to Annual Validation and Pressure Vessel Certification (PSSR), annual service and software upgrades, unlimited breakdown cover, unlimited Eschmann parts and labour, and Enhanced CPD user training. Fast and efficient remote support is available over the phone and a nationwide team of 50+ manufacturer-trained Eschmann engineers provide on-site technical assistance whenever required. They carry Eschmann original parts in their vans as standard, helping them to resolve 91% of equipment issues in their first practice visit for unmatched efficiency.
A safe future ahead
With the EU MDR certification, Eschmann is ideally-positioned to continue providing high-quality autoclaves to dental and other healthcare facilities across Europe. This achievement reinforces their reputation as a trusted provider of dental and medical devices and support, underscoring their commitment to patient safety, product excellence and innovation.