The regulatory requirements are therefore high – and rightly so. Proving compliance with regulations concerning quality assurance, quality management and data management must be seamless and traceable at all times. Ensuring that manufacturing and quality processes are correct is extremely complex and time-consuming. This makes it that much more important to have hardware and software solutions that can efficiently support these regulatory demands. Thanks to its extensive portfolio, ZEISS can support the medical industry in an effective way. ZEISS not only relies on its more than 100 years of experience in medical technology and quality assurance; as an international company, ZEISS knows the local guidelines and the associated requirements that manufacturers of medical technology must comply with in different countries.
ZEISS’s comprehensive portfolio of hardware solutions range from tactile and optical coordinate measurement machines and 3D scanners to microscopes and CT- and X-Ray solutions.
Users benefit from industry-leading resolution, accuracy, measuring speed and powerful automation functions. That said, the most important factor that enables a company to fulfill its legal requirements is the software. ZEISS software matches perfectly with the respective hardware. This helps manufacturers comply with the required step-by-step processes. The microscopes operate with ZEISS ZEN core software, which can be used on many devices, as well as with the optional GxP module.
For all other devices, the ZEISS GUARDUS MES (Manufacturing Execution System) is available. Other powerful software packages include the ZEISS CALYPSO measurement software, ZEISS FACS automation software, ZEISS PiWeb reporting and statistical analysis software, and GOM Volume Inspect, which analyzes volume data.
Equipped with such software, manufacturers can track and trace their processes at each step of production – from the raw materials to the end product. ZEISS software solutions allow companies to comply with DIN EN ISO 13485 and FDA 21 CFR Part 11. The software solutions offer a secure user administration, integrated audit trails and release management, detailed authentication concepts (including electronic signatures), and version management of documents in order to protect against other people making changes.
With these capabilities, users can automatically create certificates and test certificates from the manufacturer, monitor processes on a continuous basis, and get online access to all company-wide performance key figures and KPIs.
The enormous advantages of such an extensive portfolio are especially apparent in the field of manufacturing implants. There is a large number of implants and a wide diversity of materials used, from plastic (polyethylene, PEEK, UHMWP, etc.) to different metal alloys (stainless steel, titanium alloys, etc.).
For all the individual segments, whether the manufacturing processes utilize metal or plastic, ZEISS can offer the right quality solution – from metallography or granulate analysis to controlling incoming goods, inspecting raw materials, testing measurements, forms and positions, as well as surface analysis during the processing and finishing. All individual solutions complement each other optimally, and because they’re connected and intertwined, they seamlessly cover all the quality gates along the entire production chain.
As a result, ZEISS Medical Industry Solutions delivers certainty about the accuracy of your production processes and the quality of your products. Parts that are contaminated or have defects can be taken out of production in a targeted way. The source of an error can be precisely localized and the standard of quality continuously improved over the long term. The continuous product and process inspections will lead to cost savings. For example, the fast inspection of incoming goods will help you avoid expensive errors during later manufacturing steps, as well as help you document erroneous inventories that would otherwise lead to legal claims.
The amount of costly scrap can be reduced (which increases efficiency) and recourse claims caused by bad parts can be prevented. In short, 100% compliance and productivity do not have to be a contradiction – and that’s true everywhere. Because with its global network of application and service technicians, ZEISS is a global partner that can support manufacturers in every region of the world in meeting their quality assurance challenges and keeping their traceability and quality at a consistently high level.