Develop an entire Risk Management system for all your medical devices.
This section provides an overview of Risk Management and outlines its benefits, laying the foundation for more detailed considerations which follow.
A discussion of general requirements for medical device Risk Management Systems: top management responsibilities, risk management planning and constructing a risk management file.
This section provides a detailed exploration of the correct approach to Risk Analysis - a core component of all medical device risk management systems.
This section provides coverage of the next element of Risk Management - Risk Evaluation.
Risk control is the next major element of medical device Risk Management. This section provides detailed coverage of risk control according to ISO 14971:2019.
The next element of Risk Management is to perform an evaluation of overall residual risk. This section explains how.
How to perform a risk management review and produce a Risk Management Report.
ISO 14971:2019 calls for greater incorporation of production and post-production activities into risk management. In this section, this requirement is explored in detail.
Choose from our range of professional resources and use your existing product knowledge to build your medical device technical files
Services
Mantra Systems provides professional MDR & IVDR consulting services to companies seeking compliance & market access for any class of medical device.
Resources
Our free EU MDR Compliance Guide covers 24 topics relating to Medical Device Regulation. It's a great starting point to help direct your regulatory strategy.
Resources
Read our analysis and get guidance on medical device regulatory requirements including our observations on developments in the industry.
If you have any questions about our resources or would like a free & confidential discussion about your medical device, we'd love to hear from you.