ABOUT US NEWS SOLUTIONS PRODUCTS SERVICES CONTACT US Consulting The pre-installation, localized support and the physical installation to the treatment area. The law regarding health care devices and materials require in depth expertise. A standard office-PC may be installed in a medical environment without thinking further of the consequences. A computer being installed in a operating room or in a intensive care area is a very different process. Lack of strain relief, cable disconnections and equipment failure can result in an electric shock to the patient and the user. The installer will need to know what he or she is doing. Laws and regulations’ mission is to prevent situations in which electromagnetic radiation interferes with delicate medical instruments or the patient monitor activities. We guide you through these mandatory rules and regulations. We are certified Medical Device Consultants and we have years of experience in many european countries, in conjunction with our local partners. We have a solid track record in a variety of customer needs and solutions. We are also known to be reliable experts and we have managed large R&D projects as well as the delivery processes within the required schedules. We’ve helped a variety of different types of customers and with their needs and with this knowledge we will help you avoid repeating the same mistakes. We have trained a lot of Medical Device Experts and Biomedical Engineers in the past years in all over europe and we are still giving training days for Medical Device Manufacturers and hospitals. Our Lecturers are Dipl. Ing. Hartmut Junker and Medical Device Consultant Dirk Werth. Mr. Junker was the initiator of the first medical technology testing center in Europe and has been responsible for 3 decades. He has gained extensive professional experience in the fields of testing, auditing, certification and training, and has worked in many national and international expert and standards committees (DIN, VDE, IEC, VDTÜV, VDI, EU Commission, etc.) “. Based on this knowledge, in combination with the latest Information in the healthcare market, we are able to offer a huge spectrum of professional trainings in order to keep you up to date or to gain your knowledge. Here is a small compendium of our portfolio: – Beginner Course – Medical Devices and Patient Environment – System building inside of the patient environment – IT & Medical Devices – dos and don’ts in conjunction with Law and Norms – Leakage Current & EMC – how this influence to the safety of a system – Riskmanagement for Medical IT Systems – Conformity Evaluation – how to do – the international licensing procedure… Full service House Werth Systems is a Full Service House for solutions in patient treatment areas. We have understood that the resources in hospitals and at Medical Device Manufacturers are decreasing constantly and everything can’t be done in-house. In addition, we know that the policies tend to differ greatly between different applications and system makers. We help you to develop and to produce exactly the right solution for your need. Certifiction, Risk Management, EMC, electrical Safety, evaluation of thermal and mechanical properties, availability and creation of bill of materials are our daily business. You don’t have to start from the scratch anymore and you can save a lot of time and money if you decide to use our expert knowledge for your projects. However, it is not effective that hospitals or medical device manufacturers provide ICT solution development and IT maintenance for the patient treatment Areas, beause that is not their main business. In addition, the equipment acquisitions can be challenging when done internationally. Either the product doesn’t exist, or the selection is so wide, that a suitable and high-quality product is very challenging to find. We also offer consultancy and pre-sales services. Different types of carts, wall and table mounts require installation space as well as understanding of their weight limitations. The law of health care equipment and supplies: MDD – General requirements for professional use The professional user has to ensure that: A person who uses health care device, has the training and experience required for its safe operation; A label and instructions for safe operation are required on the device or accompanied with it; the device is used by the manufacturer in accordance with the purpose and given instructions; the device is maintained and serviced in accordance with the manufacturer’s instructions; the location is suitable for the safe use of the device; The immediate proximity or in connection with the device of the medical equipment, building components and structures, equipment, software, or other systems and objects do not compromise the performance of the device or of the patient, the health of the user or any other person; as well as the installation, maintenance and repairs of the device can be done only by someone who has the necessary skills and expertise. Critical treatment areas such as the operating room, critical care, anesthesia, etc. set the requirements for hygiene and for the method of installation. The nurse is not in charge of cable ties. Small spaces and on the ground, in the middle of patients, is not the place to start opening packages and reading the installation manuals. Werth Systems has developed processes in which the setup time in the treatment areas are reduced significantly. Device configurations are planned and prepared well in our production facilities. We will transport an almost finished device pre-configured at the scheduled time frame on location. In this way, we disturb the patients and treatment work as little as possible. About us Werth Systems is a Manufacturer of IT Solutions for the Healthcare Market. Our engineers have more than 20 years of knowledge in fanless Computerdesigns and they are specialized in developing of safe systems for the Patient Environment. Werth Systems GmbH – Germany Löhner Str. 228, 32120 Herford (Hiddenhausen) +49 (0) 5223 / 94038 - 40 info@werth-systems.com sales(at)werth-systems.com support(at)werth-systems.com Werth Systems Nordic Oy Linnanherrankuja 16, 00950 Helsinki, FINLAND +358 (0)9 348 9980 info-nordic(at)werth-systems.com sales-nordic(at)werth-systems.com support-nordic(at)werth-systems.com Copyright © Werth Systems GmbH 2020