The new regulation defines more stringent requirements for quality management and documentation. You need...
✔ To classify the medical and medical technology devices in risk classes;
✔ To have the risk and quality management systems audited by the notified bodies;
✔ To have good technical aids;
✔ To be protected against unpredictable consequences with respect to product liability.
Some practical examples...
✔ A display that is assembled using computer-controlled screwdriver systems with documented results may possibly have the tightness test omitted. As a result, this may reduce the amount of investment on expensive test equipments.
✔ A defect representing a risk of death or personal injury occurred in one individual product. As a result, the manufacturer could be forced to recall the entire series if the production of each individual device was not documented during the assembly process.
✔ A manufacturer of display units used in the operating theatre needed to demonstrate that these units are leakproof. As a result, if the display is assembled using modern, computer-controlled tightening systems, the successful completion of tightening is documented during the process.
How to meet the requirements?
In the field of tightening, our ToolsNet 8 software package can collect a wide variety of data quite independently of tightened assembly. We can also document traceability and generate unambiguous barcodes for this purpose. In addition, we have comprehensive process optimization know-how which allows us to help any industrial company save costs, become more flexible and safeguard its competitiveness.
What is important to be aware of...
✔ The Federal Medical Technology Association and other associations have already stated that up to one-third of manufacturers in Germany may be overwhelmed by the requirements of the MDR and disappear from the market.
✔ In a recent study on trends and prospects in the medical technology sector, VDI (the Association of German Engineers) warns that stringent regulatory requirements may delay or represent an obstacle to development processes in the sector. Especially small and medium-sized companies face a considerable challenge. However, it is important not to despair but to face up to the challenge and to obtain appropriate information.
Do you want to be safe and meet MDR requirements?
Do you want us to take a close look at all processes in order to find a way of ensuring and documenting quality as simply and inexpensively as possible?
Click here and ask our experts more information!