Risk Management as a DFM Tool for Improved Process Risk
In manufacturing a product, you either pay upfront, or you pay later. Manufacturers don't always use risk management as a tool to help design, develop, and manufacture safer medical devices. But, it's critical to identify where your risks are early as these can impact the completion of the manufacturing activity or process (i.e. fabrication, assembly, sterilization, etc.).
Topics covered include:
- Designing your device with manufacturing in mind
- Leveraging your Design and Process FMEAs to mitigate risks
- Knowing what inspections to do and how to improve your sampling plan