MES for medical technology and other regulated industries
Products in medical technology and other regulated industries are subject to stringent quality requirements. They must comply with laws and industry-specific regulations. These regulations are documented, for example, as part of FDA 21 CFR, GMP. The Medical Device Regulation (MDR) is also of particular importance for manufacturers of medical technology in Europe.
The manufacturing processes in these sectors are diverse and include technologies that are also used in other industrial sectors. However, all companies that manufacture medical technology products have one thing in common: without exception, they must ensure that only flawless products leave the factory.
IT-based support for the manufacturing process and its seamless documentation, including the resulting traceability, means that the use of incorrect or defective materials can be ruled out during production.
Important processes in the manufacture of medical technology include:
- CAPA process (Corrective And Preventive Actions)
- Training management
- Risk management (FMEA) and quality management
- Electronic Device History Records (eDHR)
The production of medical technology places these special demands on...
- All process steps must be fully documented. This applies to material and resources used. HYDRA X ensures traceability of all resources and material.
- It is particularly important in assembly processes to check that all work steps are carried out correctly. HYDRA X has the solution and provides integrated operator guidance.
- All deviations from the standard must be documented. With our Complaint Management, HYDRA X supports this process, which is often referred to as CAPA (Corrective and Preventive Action).
- Even before production begins, quality risk management must be in place to prevent any defects and to ensure that every product works 100%. HYDRA X helps you to watch out for quality risks during planning.
- Medical technology companies must operate a quality management system in accordance with ISO 13485. HYDRA X supports this endeavor with a broad range of functions to plan and execute in-production inspections.
- Paper-based checklists can be digitalized with the help of HYDRA X to ensure data consistency.
- You have to document and store measures of all types in the medical technology. HYDRA X supports you in this task with an integrated measure management.
MES success stories in the medical technology
The following companies rely on MPDV's manufacturing IT:
