Werth Systems is a Manufacturer of ICT equipment and an expert in Medical treatment areas. Our team of experts has extensive experience and expertise in demanding hospital environments such as operating theaters, intensive care and other areas classifiable as medical care environments. Our experts are certified Medical Device Consultants and we give training and workshops for Medical Device Manufacturers, Hospitals and Biomedical Engineers about how to set up a Medical Electrical Systems in accordance to the MDD, the Norms EN60601-1 and EN60601-1-2 and about installation and use of Devices inside of a patient environment. Our pretension is not less as to make sure that our every system conforms 100% to the actual norms, regulations, directives and laws, in order to protect patients against injuries and our customers and Operators against lawsuits and expensive down times.
Our engineers have more than 20 years of experience in development of fanless computers and we develop, produce and supply medical-PCs, medical monitors, keyboards and mouses, isolators, wall mounts and fastening solutions, Medical carts, isolating transformers, medical power strips and many others. In a short term, we have everything which is needed to setup a safe Medical Electrical System. We consult and we also manufacture and certify medical ICT-devices in accordance with EN60601-1 and EN60601-1-2. We take the responsibility as a manufacturer by signing the Declaration of Conformity (DoC), or CE-certificate. The product with these certificates is then intended for the use in treatment areas and demanding environments.
The sales of standard out of the box products is in transition – hospitals have special needs that standard products do not fulfill. Therefore, the need for strong cooperation between the manufacturers, suppliers and hospitals is required. R&D needs to be done at the user interface level and with the required conditions of the user.
The hospital world has changed. No longer is there a need to search for products that are already on the market but rather there is a need to build solutions proactively hand in hand with the customer. Werth Systems is specialized this knowledge base, and has the expertise to successfully take on this challenge.
Our expertise is to produce medical certified durable passive cooled computers for hospitals and the healthcare industry, Made in Germany. A fanless computer does not accumulate dust, dirt or microbes and spread it into the environment. We use industrial motherboards, long life cycle processors and components designed for 24/7 use in Medical businesses. Our Production Sites are ISO9001 certified and are able to produce up to 1000 Units per month. Every single unit of our computers has to pass a 24 hours test run at the end of the production. After the test run was passed, each Computer gets a Serial number and will be finally tested according to the specifications of the EN60601-1 and gets a printed Report, so that everyone can track and double check this process. Due to this extensive procedure, we are able to guarantee a zero defect production and a high quality system with consistent stability and long life span. In the end you can decide if you would like to use our own Werth Systems Brand or if you would like to get a none branded Device or a Device with your own brand on it.
Werth Systems is a Full Service House for productions and 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, nor is efficient to do in-house. In addition, we know that the policies tend to differ greatly between different applications and system makers. We help you develop and to produce exactly the right solution for your needs. Certification, Risk Management, EMC, Electrical Safety, evaluation of thermal and mechanical properties, availability and creation of bill of materials is our expertise. You don’t have to start from scratch anymore and you can save a lot of time and resources if you decide to use our expert knowledge base for your projects.
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 unit 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 circumstances in which electromagnetic radiation interferes with delicate medical instruments or patient monitoring.
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 and successful operations 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 with consistent quality and within the required timelines. We’ve helped a variety of different types of customers and with their needs and with our knowledge base 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 providing training and workshops 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 the responsible authority 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.) “.
Together with Dipl. Ing. Hartmut Junker we have a huge spectrum of professional knowledge base.
Here is a small compendium of our portfolio:
System building inside of the patient environment
IT & Medical Devices – do’s and don’ts in conjunction with Law and Norms
Leakage Current & EMC – how this influence to the safety of a system
Risk management for Medical IT Systems
Conformity Evaluation – how to do
the international licensing procedure
Product lifecycle managment, developement, designing, prototyping, supply chain managment, risk Management, certification, CE declaration, production and after sales service are very important for the complete process of making a new device. Also to pre-install computer images, or to generate computer images for Windows 7, Windows 10 or Windows embedded Environments are services which are often very useful to provide a customer with the perfect solution. We can support you in all of these stages in your Projects or we can create a complete new solution for you from the scratch. We also provide on site support in larger Projects, in order to help our customers to get the perfect solution.
Warranty extension & after Sales Service
We offer our products with two to five years of warranty and different kinds of service levels. The warranty can be a normal factory warranty where the product will be shipped to us for Service or, with the extended service levels, the replacement device is shipped to the customer on the same day, or the device may already be waiting at the customer’s premises on our behalf. With our comprehensive services, we will change the product on location in one to two days, or according to the customer agreement.
For us the essential matter is, that the disruption of the treatment areas that require repair, are as short as possible.
Operating room hours of operation price is hight, not to mention the human factors, when a surgery has to be postponed.
Also we are able to teach and to validate your own service technicians in order to maintain, repair or doublecheck solutions which was made by us. Therefor we support you with extensive instructional materials and training days at our Headquarter or directly at your side.
A hospital has a need, a space and a purpose, but can’t identify what is the exact product or service best fit for their needs. Medical Device Manufacturers have their resources bound in their main business and do not have the time to design complete Hardware Solutions by them selves.
Our job is to tell the experts what types of alternatives are suitable and optimal solutions. We will find the right products for consistent with the needs or, if necessary, we develop, certify and produce the right solution for you.
Our values and customer promise…
Werth Systems is fully aware of the responsibilities that come with this industry. When promises of products, services and deliveries are made, the promises must be kept. New departments do not have the possibility to wait for prolonged delivery dates, nor do operating theaters with a pre scheduled installation time window, thus the promises must be kept at all cost. The products and services that we offer are always suitable for the purpose, and provided with a long and durable life cycle. The products must be able to be updated and remodeled, if the intended use changes. We do not want to provide products, which are changed every three years, but we strive to deliver products that last longer, with a goal of five to eight years. No one can precisely predict the development of the future, but the products we offer are always the best of the current standards. If we do not believe in a product or service, we will speak our mind fare and square. Trust and transparency is the essential key to a successful partnership and, in our opinion, it can be lost only once. We announce unexpected changes as soon as we get knowledge of them. We will ensure that the amendment will have no impact on the customer’s operations.
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.