The medical technology industry is subject to strict regulatory requirements, such as the Medical Devices Act, MDR/IVDR and FDA guidelines.
Accordingly, the processes involved in the manufacture and distribution of safe medical devices are extremely demanding and require a consistently traceable, precise and systematic approach. The ERP system plays a central role in the validation of these processes.
- Integration of relevant processes into a QM system in accordance with ISO 13485: This includes process documentation and control, the traceability of changes and the generation of audit trails including a supporting audit manager.
- Planning, integration and validation of requirements for an ERP system: How are requirements for IT infrastructure and use cases validated in order to enable secure operation of an ERP system and the associated processes for production and service provision?
- Maintaining the validated state and controlling the life cycle: How is the validated state of a system ensured through iterative change management and risk management until it is decommissioned?
- Traceability of medical devices within and outside the ERP system: The standardized identification of medical devices via the Unique Device Identification (UDI) ensures the traceability of medical devices, which increases patient safety and optimizes market surveillance.
An ERP system explicitly specialized in the medical technology industry can make a decisive contribution to the above-mentioned requirements. You can find out how this works in our webinar on September 5, 2024, 10:00 a.m., designed exclusively for those responsible for the medical technology industry.
Focal points at a glance
- Introduction to the regulatory requirements of the medical technology industry
- The role of the ERP system in ensuring and maintaining regulatory requirements and in validating processes in the production of medical devices and the provision of services
- The role of the ERP system in the traceability of medical devices and their labeling
- Selecting a suitable ERP system for the medical technology sector
- Success stories and best practices
- Live Q&A with experts
Your added value
- You will learn which regulatory requirements must be observed in connection with the operation of an ERP system and its implementation
- They learn how they can meet the requirements for system validation with the help of a suitable ERP system
- You will gain an insight into end-to-end traceability 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
Organizational details
- Sector: Companies in the medical technology industry
- Target group: IT managers, GF, QM managers, RA managers and all interested parties who are not yet using an ERP solution or are interested in replacing their existing solution with the GUS-OS Suite.
- Location: virtual/online
- Date and time: September 05, 2024 at 10:00 a.m.
- Costs: free of charge
