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This webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

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strategies for 510 k applications for medical devices software

Strategies for 510 (k) Applications for Medical Devices Software | 510-857-5896 |


Instructor Profile:

MukeshKumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. | 510-857-5896 |



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 usages in medical devices, there is significant confusion regarding updating software applications in new 510(k) devices and the additional testing requirements. 

Why Should you Attend:

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. | 510-857-5896 |


Objectives of the Presentation:

The objectives of the presentation are to talk about: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 | 510-857-5896 |


Who can 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 | 510-857-5896 |


Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdfformate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.

Recorded Session - How it works

  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdfformate will be mailed to you
  • Get certification of attendance. | 510-857-5896 |

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Get Connected : | 510-857-5896 |