Employee Expense Reimbursement Fraud: Detection, Prevention and Deterrence
Location: Attend Live Webinar
Date: 26-Feb-2015: 10:00 AM PST
Duration : 90 Mins

Speaker: Mukesh Kumar

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products.

Course Description:

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 much 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 it used to be 10 years ago. This session will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

Course Objective:

This seminar will provide practical tips and useful suggestions regarding testing requirements and documents to be included in the 510k applications for medical device software. Practical strategies for complying with the current rules will be discussed using case studies and examples.

Course Outline:

• 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

 Target Audience:

• 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

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Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com