View / Edit Order
0 Items

 Catalog: Course Details

Return to Course List    
Course Description
Show / Hide Details  

Course Name

OL-MDM-OV14971:2007: Recorded Webinar - Overview of ISO 14971:2007

Slides

IMPORTANT: This is a recorded webinar.
Note: This course is free for BSI Internal Employees
The recorded version includes both Audio and the Web Conferencing Video.

Description

BSI’s “Recorded Webinar - Overview of ISO 14971:2007” provides information on the impact that ISO 14971:2007 has on the decision making process of a medical device manufacturer who is registered or soon to be registered to ISO 13485:2003. This webinar offers medical device professionals insight into how ISO 14971:2007 can improve business and risk management efforts. An experienced instructor will lead participants through exercises and discussion points, and participants are encouraged to ask specific questions about ISO 14971:2007 and risk management as applicable to their organizations.

Prerequisite

General awareness of ISO 13485:2003 and experience in a medical device manufacturing environment is recommended.

Topics Covered

  • Understand the Clauses of ISO 14971:2007
  • Discuss Statements of Applicability
  • Understand How ISO 14971:2007 applies to ISO 13485:2003
  • Understand How Management is Expected to Support the Implementation of ISO 14971:2007
  • Discuss Leveraging Existing Efforts to Help Meet ISO 14971:2071 Requirements
  • Identify the Variables that Will Drive the Cost and Duration of Implementation

    • Who Should Attend

  • Quality decision makers on management system strategy at Medical Device Manufacturing Firms
  • Management Team of Medical Device Manufacturers
  • Quality managers
  • Auditors of medical device manufacturing firms (internal and external)
  • Consultants
  • Regulators

    • Course Timing

    This recorded version takes about 2 hours to complete.

    System Requirements

    An internet connection with at least Microsoft Internet Explorer 5 or Netscape 5. Also, Corporate Firewalls may prevent the dowload of the MP3 Audio file which can cause the course to hang. Only your IT department can determine if MP3's are being blocked.

    System Requirements

    Please contact BSI (solutions.msamericas@bsi-global.com) with "eLearning Certificate" in the subject line to obtain a Certificate of Completion.
    A certificate will only be provided to each individual person who has purchased a seat for the recording.

     NOTE: E-Learning courses are typically available immediately upon enrollment.

    E-Learning
    Course DurationCourse Fee 
    0 DaysUSD $75.00Please log in to enroll.