Strategies for 510 (k) Applications for Medical Devices Software

Duration: 60 Minutes
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. The level of details expected in a 510(k) application is very different from what used to be 10 years ago. 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.
510(k) Requirements
Instructor: Mukesh Kumar
Product ID: 500635

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.

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
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
$375
Recorded Session for one participant
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mukesh Kumar, 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. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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