EU Quality Management System Certificate
We are proud to announce that our Bed Head Units are certified under Regulation (EU) 2017/745 for medical devices. The compliance of our quality management system has been verified by IMQ S.p.A., Notified Body no. 0051, which has issued the EU Quality Management System Certificate (no. 187/MDR). Certification Details Manufacturer: LOMAR SRL, Flero (BS), Italy Certification: Compliant with Annex IX (Chapters I and III) of Regulation (EU) 2017/745 Certified Device: Bed Head Units Risk Class: IIb Date of Issue: 20/02/2025 Valid Until: 19/02/2030 Quality and Safety Assurance This certification confirms that our quality management system ensures compliance with the highest safety and performance standards required for medical devices. The validity of the certificate is subject to continuous surveillance by the certifying body to guarantee ongoing adherence to quality standards. For more information about the certification and technical specifications, please contact us or consult the official documentation.
ISO 9001 Certification: Excellence in Quality Management
We guarantee quality, efficiency and customer satisfaction through a certified management system
Our company is ISO 9001 certified, an international recognition that demonstrates our constant commitment to improving business processes and meeting the needs of our clients. By adopting the highest quality standards, we ensure that every phase of our work adheres to rigorous criteria of efficiency, reliability, and continuous improvement. ISO 9001 certification is tangible proof of our dedication to quality management and to creating lasting value for our clients and partners.
ISO 13485:2016 Certification – Quality and Safety in Medical Devices
An ongoing commitment to ensuring compliance and reliability in the healthcare and medical device industries
Our company is ISO 13485:2016 certified, an important international standard that demonstrates the adoption of a quality management system specifically designed for medical devices. This certification ensures that our production processes and products meet regulatory requirements, are safe and reliable, and address the needs of the healthcare sector. With ISO 13485:2016, we are committed to maintaining the high-quality standards required to improve patient safety and the effectiveness of medical devices, ensuring careful and rigorous management throughout every stage of the product lifecycle.