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ISO 13485 Medical Devices Quality MS- Implemener

1. Brief Description:

The ISO 13485 Medical Devices Quality Management System (QMS) Implementer course is designed to provide participants with the knowledge and skills required to implement an ISO 13485 compliant QMS for medical devices.

2. Key Topics:

  • Understanding the ISO 13485 standard and its requirements
  • Developing a QMS implementation plan
  • Establishing quality policies, objectives, and procedures
  • Documenting the QMS
  • Implementing and maintaining QMS processes
  • Performing internal audits and management reviews
  • Continual improvement of the QMS

3. Audience:

This course is intended for individuals who are involved in the implementation, management, or maintenance of a QMS in the medical devices industry. It is also suitable for those who seek to become ISO 13485 Lead Implementers.

4. Learning Objectives:

By the end of the course, participants will be able to:

  • Understand the purpose and benefits of ISO 13485 standard for QMS in the medical devices industry
  • Interpret the requirements of the ISO 13485 standard and apply them to a QMS implementation plan
  • Develop and implement quality policies, objectives, and procedures
  • Document and maintain the QMS
  • Perform internal audits and management reviews to ensure the effectiveness of the QMS
  • Continuously improve the QMS based on performance metrics and feedback
  • Prepare for the ISO 13485 Lead Implementer certification exam.

More Details

Day 1: Introduction to ISO 13485 and initiation of a MDQMS

Day 2: Plan the implementation of a MDQMS

Day 3: Implementation of a MDQMS

Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit

Day 5: Certification Exam

Fees for certification and assessments are incorporated into the cost of the course. ConimCert will provide a comprehensive set of educational materials that include explanations, guidance, and practical examples. Upon finishing the course, participants will receive a statement verifying their accomplishment, which carries a noteworthy amount of CPD (Continuing Professional Development) credits. If a student does not pass the exam, they have the option to retry within a year at no additional charge. For more details, feel free to reach out to us at trainings@conimcert.com.

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

Exam duration: 3 hours

Exam type: Test

Exam format: Computer based

Exam premise: Conimcert premise 

Retake: Yes

Retake period: 12 months

Open book: No

Additional Information

Price: 950 AZN