The A Comprehensive View of FDA Regulations for Medical Devices 2016 is a seminar that covers topics such as:
- The requirements to market a medical device in the US including device classification and conformity assessment paths
- The law, regulations, and policies that FDA applies for medical device
- How UDI will affect medical devices and how to prepare for implementation
- The quality management systems that govern the design , manufacture, installation, and servicing of medical devices for the US market
- Which devices must be tracked and how to set up and audit the system
- The rules for Medical Device Reports (MDRs) and their relationship to complaints
- The role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
- Correcting devices already shipped and when to report to FDA
- The issues manufacturers face by reviewing Warning Letters related to the topics covered
- Inspectional observations and how to respond to a Form 483
The A Comprehensive View of FDA Regulations for Medical Devices 2016 brings together attendees from medical device manufacturing companies:
- Quality engineers
- Quality managers
- Regulatory affairs managers
- Quality assurance and quality control
- R&D managers
- Regulatory affairs professionals
- Product design and development
- R&D engineers
- Production managers and supervisors
- Operations managers
- Risk managers
- Manufacturing engineers
- CAPA team members
- Complaint system team members
- Device marketing personnel