The term ‘medical devices’ covers a variety of manufacturing processes encompassing a diversity of technologies and materials for the production of devices, utilized for medical procedures.
Requiring the device and the individual components to work faultlessly, the manufacture of medical devices is traceable and conforms to standards outlined in the European Directive for Medical Devices. Other continent and country associations (such as the FDA) have also recognized varying number of the classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.
The stringent quality procedures often implemented by manufacturers conforming to such standards, is ideal for Vision Engineering’s Mantis Elite, where every individual component is inspected 100% and measured to very tight tolerances, Advantages of Vision Engineering’s Stereo Inspection Range
Medical device components, whether they are stents, ceramic implants, dental prosthetics, catheters, require 100% inspection. Unlike other industries that utilize batch inspection, 100% inspection requires engineers or technicians to be peering through a microscope for long period of time inspecting for defects such as debris, burrs or hairline cracks and chips. This can often cause tiredness and general fatigue as well as eye strain. However, the stereo range from Vision Engineering benefit from an ergonomic viewing head, promoting accuracy and productivity. Advantages of Vision Engineering’s Metrology Range
If a components manufactured for medical devices requires measurement it usually means the dimensional accuracy is very tight and often down to microns. Equally, both hard and soft material used for such devices require careful handling because any deformation during processing can cause functionality failures. The non-contact method of measuring (using Vision Engineering’s metrology range), means components can be measured for dimensional accuracy without ever contacting the part, unlike a probes or vernier calipers. Types of Medical Devices
The classification of medical devices in the European Union consists of four classes, ranging from low risk to high risk. Within these classes is a variety of devices, which for ‘our’ understanding, I have segmented into the following categories: Precision Engineering Plastics & rubber Electronics Ceramics