How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry 2015 is a webinar that covers topics such as:
- Defining and supporting Level of Concern determination
- Define software use in medical devices. What makes your software a medical device?
- Risk assessment/mitigation and its relationship with the LOC
- What specific software related documentation is required? How does the Level of Concern (LOC) determination impact this?
- V and V (verification and validation)
- Software change management and its relationship with the LOC
- Could the special 510(k) or abbreviated 510(k) apply to your application?
- When is a 510(k) needed for Off the Shelf (OTS) software?
- Labeling of software devices
- Exemptions to the 510(k) requirements
How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry 2015 is intended for:
- Project managers
- Regulatory managers
- Product development managers
- Regulatory specialists who compose 510(k) applications for software
