Medical devices– when quality is crucial for life, traceability is no longer an option
In the medical equipment industry, impeccable quality is crucial at all times. The sector is also undergoing a regulatory shift that will affect every single step of the manufacturing process. Traceability is no longer an option. When it comes to the medical equipment industry, the main challenges encompasses quality control, secure processes, confidentiality, traceability, risk and safety management, safely stored data, compliance with regulations, and long-term reliability.And we from Atlas Copco are experts on working with our clients' main challenges. When all the challenges are addressed, focus can shift to parameters like productivity enhancement, ergonomics and operator security.
Large impact regulation
The implementation of the EU Medical Devices Regulation (MDR) is currently taking place. Between 2017 and 2020, all manufacturers of medical equipment must establish a risk and quality management system, and have it audited. The MDR is an EU regulation, but since it also addresses all European distributors of medical equipment, the implications are global.
Whereas data from the manufacturing process used to be stored voluntarily for some companies, the practice will become mandatory with the MDR. In many ways, this is a welcome development, since it can enhance life integrity, patient security. The traceability will be of high value when determining liability if errors have occurred in the equipment.
Nevertheless, it can be difficult to implement these necessary changes in a short period of time.
But how to meet the requirements and assure MDR compliance?
At Atlas Copco, this connectivity and traceability is already at the heart of what we do. In the Smart Connected Electronics solutions, we help our clients to make sure that data from every single tightening, at every single workstation, is stored and traceable. Providing smart screwdrivers and controllers that are fully integrated error-proofing solutions, we ensure increased efficiency and full connectivity in the internet of things era is an important part of the Atlas Copco offer to the medical equipment industry. On top of that, data from the tools is processed and analysed in order to make more well-informed business decisions in the future. With the MDR in place , each manufacturer must keep the data for every single equipment part with a serial number, for twenty years. Having worked with high-profile industrial clients for many decades, we know the importance of handling such vast data flows in a secure and reliable manner. The new regulatory framework may seem overwhelming at first, but by implementing connected tools, securing long-term data storage and enabling new types of data-driven insights, the new industry 4.0 solution might prove to be checking all those wish list boxes − while saving both time and money.