ISO 13485:2016 FOUNDATION COURSE

COURSE OBJECTIVES

  • Importance of Quality Management System with respect to ISO 13485 and Medical Devices.
  • Important Processes of Quality Management System and their significance.
  • Process approach, 7 Quality principles, risk based thinking, quality policy & objectives and management review & internal audit.
  • Risk Analysis and validation of Process (Clean room & sterilization) as per ISO 14971, ISO 14644 & ISO 11135.
  • Insight into the foreign body requirements for medical devices. Special emphasis on US and European Market.
  • Incident reporting & CAPA process (Course of action and required formats).

COURSE METHODOLOGY

  • Read and Find
  • Practice by doing
  • Fill in the blank
  • Quizzes
  • Group Tasks

WHO SHOULD ATTEND?

  • Individuals involved in Medical Devices Quality Management.
  • Individuals interested to pursue a career in Medical Devices Quality Management.

WHY EUROTECH?

  1. Modern and Kinesthetic Techniques of Learning.
  2. Experienced tutors- go through rigorous criteria for selection and continuous assessment.
  3. All Training courses are followed up with a feedback.
  4. Continuous monitoring of every candidate.
  5. Personal attention to every candidate.
  6. Friendly learning environment.
  7. Course content is prepared taking into consideration the needs of various delegates.
*Note: In house courses are delivered at client locations as per requirements.