
Repair and Maintenance in Medical Devices
Repair and maintenance are two very important terms in the asset management field. The terms we mentioned are valid not only for medical devices (Orthopedic
Repair and maintenance are two very important terms in the asset management field. The terms we mentioned are valid not only for medical devices (Orthopedic
One of the biggest challenges during MDR transition is to understand what brings new regulation to post market surveillance requirements. Click here for the full
In order to provide uninterrupted and effective health services in hospitals, a wide variety of materials, devices (such as orthopedic surgical power tools) and services
With MDR, the reprocessing of single-use devices (MDR Article 17) have also entered our lives. This issue was not previously regulated by the law. Click
Surgical power tool systems, which are used in surgeries and come into contact with the body, are devices that frequently come into contact with liquids.
Cast Saw Injuries While Removing Cast Cast saw injuries occur during the removal of the cast after the cast has fulfilled its function on the
Oscillating surgical saw blades are used for bone shaping in total knee arthroplasty. In order to facilitate these cutting procedures, cutting guides have been designed
Post operative medical device disinfection process is a crucial step to eliminate the microorganisms after the medical device is used on a patient, therefore, if
Aseptic loosening, periprosthetic joint infection are two major complications of hip and knee arthroplasty. In this article, we will try to show you how saw
Whereas old Medical Device Directive has these obligations but new Medical Device Regulation has new ones that are more detailed. Here are the manufacturer’s basic
Oscillating surgical saw blades are used for bone shaping in total knee arthroplasty. In order to facilitate these cutting procedures, cutting guides have been designed
Nobody wants a medical device that they manufacture to harm a person or result in death. The important thing is to be able to take
Surgical power tool systems used in orthopedics and traumatology surgeries are produced with pneumatic, electrical or battery options. With the development of lithium-ion battery technology,
If you are not a small company, you might ask yourself: “Shouldn’t we have already a responsible person for regulatory compliance?” Answer is “no”. All
All “non-EU” medical device manufacturers should have an authorised representative, if they want to sell their products within EU countries. This representative plays a role
The forward & reverse (F&R) modes (Kirschner Wire Driving Modes) of the power tool are used while drilling with surgical power tools in orthopedic operations.
Blood-borne diseases pose a significant risk for healthcare workers, especially in operating rooms. There are several ways these diseases can be infected to the surgeon.
What should be the speed (rpm) of the drill handpiece in trauma operation? In drilling and cutting processes related to the bone, the temperature of
Saw Cut Accuracy in Knee Arthroplasty In this article, we’ll try to explain to you Saw Cut Accuracy Arthroplasty. Since the use of computers in
Bone cutting and drilling are important clinical applications that may affect the health and recovery process of patients after their operation. Today, bone cutting and
Surgery is a fact that has emerged with humanity. In primitive ages, surgery was not a separate specialty. In these times, people performed surgical procedures
In this article, we’ll try to explain to you Pandemics and Single Use Devices. Click here for World Health Organization page about Coronavirus. What is