Strategies for 510 (k) Applications for Medical Devices Software Webinar training seminars presented by Online Compliance Panel register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

Strategies for 510 (k) Applications for Medical Devices Software Webinar  

 Email information about this seminar Strategies for 510 (k) Applications for Medical Devices Software Webinar by Online Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like Strategies for 510 (k) Applications for Medical Devices Software Webinar by Online Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Online Compliance Panel on FindaSeminar.com Other seminars from Online Compliance Panel

By:

Online Compliance Panel   

For:

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

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. (see full course description)

 

 Seminar / Training class dates & locations

 
 SORT RESULTS BY:

 DATE

LOCATION

SELECTED VENUE DETAILS

Facility Name: 
Address:





Registration Information:

Event cost:  $
USD

class times and cancellation policy

 
 




 From 
 To 
 Click to register by Register by fax for Strategies for 510 (k) Applications for Medical Devices Software Webinar training seminar Register by mail for Strategies for 510 (k) Applications for Medical Devices Software Webinar training seminar Register by phone to attend Strategies for 510 (k) Applications for Medical Devices Software Webinar training seminar

Print payment approval request form Strategies for 510 (k) Applications for Medical Devices Software Webinar training seminar

Pre-Registration questions? Find answers in our registration FAQ or Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request

 
 

 

share this page 

print the agenda print agenda for the Strategies for 510 (k) Applications for Medical Devices Software Webinar seminar

 

 

Training Course Syllabus:


Strategies for 510 (k) Applications for Medical Devices Software Webinar

Time: 10:00 AM PST | 01:00 PM EST

Duration: 60 Minutes

Instructor: Mukesh Kumar

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 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.

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

Seminar Summary:

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. (see full course description)

print this agenda print agenda for the Strategies for 510 (k) Applications for Medical Devices Software Webinar training seminar

 view dates and locations for this seminar

 

 

 

Custom Search