Course duration is the Learning Management System (LMS) access available to the student. However, the student can complete the course early or whenever within 30 days.
Eligibility criteria:
- Knowledge of ISO 13485 -Medical Device-Quality Management System
Course material:
- PowerPoint Presentations
- Reference material
- Articles
- Case Studies
- Case Reference Material
- Videos
Career Prospects:
- Team Member
Foundation Course - ISO 13485 Medical Device - Quality Management System
Foundation Course ISO 13485:2016
- A course aimed at giving you an overview of the key concepts, frameworks and regulations related to MDD - Quality Management systems, compliant to ISO 13485.Understand how ISO 13485 can be applied to enhance organizational performance and achieve operational excellence. The ISO 13485 framework also assists organizations in enhancing quality standards for meeting customer requirements.
- This course is open to anyone that plays a role in any process, for enhancing the MD-QMS in any organization.
Key Outcomes:
- Concepts, methodologies and principles of ISO 13485
- Gain insight into the key elements and processes for implementing a MD-QMS in line with ISO 13485
- Recognize that ISO 13485 standards help manufacturers and suppliers eliminate risks of failure, defects, wastage, malfunction in their processes
- Understand the correlation between ISO 13485 and other international standards
Course Chapters:
Chapter 1 Introduction to Course
Chapter 2 Introduction to Standard & Quality Related Concepts
Chapter 3 Requirements of Standard I
Chapter 4 Requirements of Standard II
Chapter 5 Requirements of Standard III