The Ombu Library, in the Employee Competence and Training aisle, has an article on determining training effectiveness in the context employee competence. It includes information from the recently published ISO Handbook on ISO 13485:2016 and ISO 10015:1999 Quality Management – Guidelines for Training.
All posts by AdminOMBU
Determining Training Effectiveness
Determining Training Effectiveness (October, 2017 – 1 Page)
Hazard Analysis and pFMEA
Hazard Analysis and pFMEA (October, 2017 – 2 Pages)
Identifying NBs and AOs
Identifying NBs and AOs (October, 2017 – 1 Page)
FDA Issues Interoperable Medical Devices Final Guidance Document
On September 6, 2017, FDA-CDER & CBER issued a final guidance document entitled Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
The guidance document defines an interoperable medical device as a device with the ability to exchange and use information through an electronic interface with another medical product or non-medical product.
During the design phase the guidance recommends applying these considerations to the interface:
- Purpose of the electronic interface
- The anticipated users
- Risk management
- Verification and validation
- Labeling considerations
- Use of consensus standards
Pre-market submission should include:
- A device description
- Risk analysis
- Verification and validation
- Labeling
The Federal Register announcement says that FDA recognizes that it would take up to 60 days to put the guidance document in place. Pre-market submissions for interoperable medical devices made after 60 days should include the information covered by the guidance.
FDA plans to hold a webinar on the guidance document on October 26, 2017.
Equipment Utilization Metrics
Equipment Utilization Metrics (October, 2017 – 3 Pages)
Production Equipment Maintenance in QSR
Production Equipment Maintenance in QSR (October, 2017 – 5 Pages)
Kits, Packaging Configurations, and Unit of Use
Kits, Packaging Configurations, and Unit of Use (October, 2017 – 5 Pages)
Preparing for eMDR
Preparing for eMDR (October, 2017 – 2 Pages)
Medical Device Excise Tax
Medical Device Excise Tax (October, 2017 – 1 Page)