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…