How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry 2015
31 Mar 2015
Webinar
Description
Topics
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
Who should Attend
Project managers
Regulatory managers
Product development managers
Regulatory specialists who compose 510(k) applications for software
Past Events
How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry 2015 - 31 Mar 2015, Webinar (50557)
Important
Please, check "How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry" official website for possible changes, before making any traveling arrangements
