We provide expert knowledge for the medical device life cycle management process with a holistic data structure approach. Management systems shall cover the entire product life cycle of the medical devices. The life cycle starts with the idea and ends with the time point the product is discharged. Therefore, the interfaces between different disciplines, especially the transition from a development project to the post-market phase, are important and solid. Last but not least, the regulation, guidelines, and standards are subjects of change and needs to be monitored and controlled.
This multi-dimensional interaction of procedures and processes demands an excellent understanding of the interface and interaction between the disciplines. We have developed methods to monitor the legal requirements and build a comprehensive data and content flow customizable to your needs.
We use this workflow also for management system assessment to identify potential gaps or weak interfaces. The evaluation is performed by adhering to the ISO 31000 Risk Management Guidelines. This risk management considers the company strategy and is not limited to single products as the ISO 14971 Risk management for medical devices.