Safe medical devices with the help of ERP software: validated processes along the entire value chain

Medtech safe medical devices - GUS-OS Suite - GUS ERP

The medical technology industry is subject to strict regulatory requirements such as the Medical Devices Act, MDR/IVDR and FDA guidelines.

Accordingly, the processes of manufacturing and distributing safe medical devices are extremely demanding and require a consistently comprehensible, precise and systematic approach. The following requirements play a central role here:

    • Compliance with and monitoring of regulatory requirements: This includes process documentation, traceability and risk assessment of changes as well as the generation of audit trails including a supporting audit manager.
    • Consistent quality management and traceability throughout the entire life cycle of a medical device: from the procurement of the required raw materials to the end product, supported by supplier and customer management systems where possible
    • Seamless supply chain management to ensure production and service provision
    • Warehouse management to ensure the availability of the required raw materials and products
    • Corporate management in a validated process environment, ensuring that all business processes and systems meet strict quality, security and compliance requirements.

     

    An ERP system explicitly specialized in the medical technology industry can make a decisive contribution to the above-mentioned requirements. Find out how this works in our webinar on May 8, 2024, 10:00 a.m., designed exclusively for those responsible for the medical technology industry.

    Focal points at a glance

    • Introduction to the topic and importance of safe medical devices
    • The role of ERP in ensuring quality requirements and validation of processes in the production of medical devices and in the provision of services
    • Selecting a suitable ERP system for the medical technology sector
    • Success stories and best practices
    • Live Q&A with experts

    Your added value

    • They learn how they can manufacture safe medical devices with the help of a suitable ERP system
    • You will gain an insight into the validation of processes along the entire value chain of medical devices
    • You will learn which criteria you can use to select a suitable ERP system for your company
    • They will learn from practical examples how they can shape the digital transformation and optimization of their processes.

    Organizational details

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