Webinars >>510(k) Guidance
FDA’s Current Rules for Software 510(k) Applications: Evolving Regulations
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​Several medical devices use either off-the-shelf or custom software. A couple of guidance documents from FDA written almost a decade ago are the only official comments from FDA to assist manufacturers understand the current FDA requirements. Despite a long history of software usage in medical devices, there is significant confusion regarding updating software applications in new 510(k) devices and the additional testing requirements. The level of details expected in a 510(k) application is very different from what used to be 10 years ago. This seminar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.  
Areas Covered in the Session:
  • FDA definitions for software in medical devices
  • What makes your software a medical device?
  • What specific software –related documentation is required?
  • Risk Assessment/Mitigation for software related risk in medical device operation
  • Software change management and its relationship to risk assessment
  • When is a 510(k) needed for Off the Shelf (OTS) software?
  • Could the Special 510(k) or Abbreviated 510(k) apply to your application?
  • Exemptions to the 510(k) requirements
  • Labeling of Software devices
Why should you attend:
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This seminar will provide practical tips and useful suggestions regarding testing requirements and documents to be included in the 510(k) applications for medical device software. Practical strategies for complying with the current rules will be discussed using case studies and examples of scenarios.
Who will benefit: 
  • Regulatory specialists who compose 510(k) applications for software
  • Manufacturers of medical devices
  • Product Development managers
  • Regulatory managers
  • Project managers and documentation specialists
  • Medical writers
  • Medical device IT specialists
  • Medical device and 510(k) consultants
  • Import Supervisors
  • Customs Brokers
Date: February 14, 2023
Time: 12 PM ET        
​Duration: 60 Minutes

Speaker
Mukesh Kumar, PhD, RAC, Brij Strategic Consultations
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    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com