MDSAP and Regulatory Transitions - The Basics Virtual Training

Content
2 modules

Difficulty
Basic

Rating

Course Length
130 mins

Instructor
NSF Medical Devices

Price
$199.00

Description

NSF International’s web-based virtual training course provides the basic knowledge to prepare for MDSAP, helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from global Quality Systems expert, Kim Trautman, a former U.S. FDA official and key member of the original MDSAP development team. Kim also authored and led the implementation of the current U.S. FDA Quality System regulation and is a globally-recognized leader of continuing harmonization efforts for ISO 13485.

 

WHAT YOU GET

  • A 90 minute video presentation from MDSAP recognized expert, Kim Trautman
  • Competency assessment certification to add to your company’s training files (2 hours, including exam)

 

Objectives

By the end of this course, you should:

  • Understand the new regulatory audit findings/nonconformance grading system and know what grades trigger regulatory follow-up within MDSAP
  • Learn the value of the MDSAP audit model
  • Be familiar with the premise of the MDSAP audit time calculations
  • Be familiar with the basic information to be included in the MDSAP audit report
  • Understand the MDSAP timeline and other upcoming regulatory changes

Certificate

By completing/passing this course, you will attain the certificate Medical Device Certificate

1
MDSAP - Overview - Kim Trautman
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2
MDSAP and Regulatory Transitions - Final Exam
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Added about 1 hour ago, by Anonymous
Learned a lot from this training module. Its worth buying this module
 
Added 5 days ago, by Jose
 
Added 5 days ago, by Rhonda
4-stars. The content is excellent, but a bit dated. Per the narrator, this was recorded in 2017. Maybe an update would have been good, since this goes into effect shortly. (Date of training performed: 10Dec2018.
 
Added 7 days ago, by Ronit
 
Added 19 days ago, by Anne
 
Added 19 days ago, by Edgar
 
Added about 1 month ago, by Michael
 
Added about 1 month ago, by Nate
 
Added about 1 month ago, by Huiyu
 
Added 2 months ago, by Anonymous

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