Does your software provide computerized alerts and reminders for providers and patients? Or clinical guidelines, condition-specific order set, focused patient data reports and summaries, documentation templates, diagnostic support or contextually relevant reference information?
If so, your clinical decision support (CDS) software might be regulated as a medical device.
You need to have a good grasp of the latest legal, regulatory and compliance nuances of FDA’s guidance on CDS software to be able to clarify the type of CDS software functions affected by legal developments like the 21st Century Cures Act.
Join WCS and John E. Lincoln, is Principal of J. E. Lincoln and Associates LLCfor a comprehensive overview of current guidance on CDS software:
- Master the legal, regulatory, and compliance nuances of the FDA’s guidance
- Determine what types of CDS software functions do not meet the definition of a device as amended by the Cures Act
- Assess which types of software meet the definition of a device for which the FDA may not enforce compliance under device requirements
- Comprehend how the FDA intends to leverage the Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations External Link Disclaimer (IMDRF Framework) in its risk-based approach to CDS regulation
- Use an FDA “model” to properly document the required validation of your CDS software
- Establish compliant best practices for your CDS software by understanding the legal, regulatory and compliance nuances of the FDA’s guidance. Join us by registering today.
Who will Benefit
- Medical device companies
- Software manufacturers/ engineers
- Quality, regulatory, and compliance specialists at medical device companies
- FDA attorneys
Industries who can attend
This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel