This seminar is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company’s face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant.
This course will ensure that Device companies will know exactly what documentation needs to be prepared. They will also know how to ensure the documentation is prepared correctly so the software portion of the submittal will be in compliance preventing delays of the 510K approval.
However, you will soon be overwhelmed by continuing to apply paper document methods and approaches to software configuration and validation. Rather than wait to be surprised by unexpected situations, or to implement requirements haphazardly, it is better to understand what the hands-on challenges of dynamic requirements as they push the boundaries of technology and new applications.
This seminar is also an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.
Who Should Attend:
- Quality Assurance Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Research and Development Departments
- Compliance Departments
- Production Departments
- Documentation Departments
- Operations Departments
- Medical Device Software Engineers
- Medical Device Software Validation Departments
- Medical Device Software Compliance Engineers
- Document Control Teams