Loading ...

Read More Courses
Read Less Courses
Course Dates Course Details Related Courses

Course Dates

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

Course Details

Objectives

  • Understand the requirements of ISO 13485:2016. 
  • Apply process-based thinking to an ISO 13485-compliant quality management system.
  • Understand what is and is not a medical device, and how medical devices are classified and regulated.
  • Establish the relationship of ISO 13485 to ISO 9001 and the FDA Quality System Regulation 21CFR820.
  • Review the QMS requirements in the ISO 13485:2016 standard.
  • Plan the activities of a registration audit.  

Topics

  • The role of the quality management system
  • The process approach to quality management systems
  • ISO 13485 background
  • ISO 13485:2016 requirements: clause by clause
  • ISO 13485 registration

Who Should Attend

This course is appropriate for anyone who needs to know how to meet the requirements of ISO 13485, including management representatives; RA/QA managers/engineers; internal auditors; compliance and legal; product, project, and program managers; R&D or engineering managers; and other cross-functional team members. 

  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs

    1.5

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

arrow
REQUEST A PROPOSAL Or ask a question!
Get answers right now. Call
us flag

US OfficeWashington DC

1.800.472.6477

EU OfficeCork, Ireland

eu flag

+353 21 212 8530

© Oriel STAT A MATRIX. All Rights Reserved. Site Map Privacy and Legal