After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect for design control for medical devices. Since the design control regulations became effective, many warning letters has been issued for failures to fully implement the controlling regulations.
This webinar will focus on the records that make up the key regulatory documents, the DHF, DMR and DHR. We will discuss the effect of Change controls on the aforementioned regulatory documents, as any changes in design and production must be proposed, accepted, changes documented and verified to have no unintended consequences on the device.
This webinar is beneficial for any professional who is involved with a design effort from the time management releases funding to develop a new device design.
- The Design History File (DHF)
- The Device History Record (DHR)
- The Device Master Record (DMR)
- Change Controls
- Impact of Change Controls on each
- Documentation associated with each
- Research and Development Departments
- QA/QC Departments
- Regulatory Affairs Departments
- Quality Management Teams
- Documentation Departments
- Combination Products Design Personnel
- Production Teams
- Marketing Teams