Overview

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.

Webinar Takeaway

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
  • Marketing
  • Consultants

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

Faculty John E Lincoln


John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

Faculty John E Lincoln

Choose a Purchase Options

$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$399

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.