ISO 13485:2016 - Understanding the Introductory Clauses
What you'll learn
- Introduction to the ISO 13485 standard.
- Understanding the scope of ISO 13485.
- Applicability to various organizations within the medical device supply chain.
- Importance of adherence to the standard for regulatory compliance.
Requirements
- An internet connection.
Description
Welcome, learners, to our exciting journey into the realm of medical device quality management. This course, titled "ISO 13485:2016 - Understanding the Introductory Clauses," is your gateway to a comprehensive understanding of ISO 13485 and its significance in the medical device industry.
Why ISO 13485 Matters: A Brief Overview
ISO 13485 is the cornerstone of quality management systems (QMS) for medical devices. It provides a framework for ensuring the safety and effectiveness of medical devices throughout their lifecycle. Understanding ISO 13485 is not only crucial for regulatory compliance but also essential for building trust among stakeholders, including patients, healthcare professionals, and regulatory authorities.
Who Should Attend:
Aspiring quality assurance professionals looking to break into the medical device industry.
Medical device manufacturers and suppliers seeking ISO 13485 compliance.
Regulatory affairs specialists navigating the complex world of medical device regulations.
Auditors and consultants who are eager to enhance their expertise in ISO 13485.
Join Us on This Educational Journey
We invite you to join us on this educational journey, where you'll gain insights that can transform your career and your organization's approach to quality management. ISO 13485 is more than just a standard; it's a roadmap to excellence in the medical device field.
Certificate of Participation
A certificate of participation will be awarded by the course provider once you watch all videos and share all screenshots with the system built into the curriculum. The certificate takes time in processing as it is not awarded by Udemy.
Ready to Get Started?
Enroll in our free basic course on ISO 13485 today and gain access to these valuable lectures.
Who this course is for:
- Quality assurance professionals in the medical device industry.
- Individuals seeking a foundational understanding of ISO 13485.
- Medical device manufacturers and suppliers.
- Auditors and consultants involved in ISO 13485 compliance.
- Regulatory affairs specialists.
- Beginners who are entering the market space of medical devices
Instructors
- 4.0 Instructor Rating
- 1,389 Reviews
- 18,037 Students
- 8 Courses
S. M. Waqas Imam is an Industrial Engineer by qualification and has served in the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor.
He had also served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA.
He also served as expert Blog writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.
Recently he is associated with Medical Device Community as Ambassador. He also writes compliance articles on Surgical Units.
- 4.1 Instructor Rating
- 3,707 Reviews
- 47,487 Students
- 40 Courses
Exoexcellence is established to suffice the intellectual gap in the market for management system consultancy and training. This profile is an endeavour of the Training Department of Exoexcellence. The Exoexcellence team wants to make sure that high-quality training programs and those which are offered at high-end prices are easily accessible at an affordable cost while keeping the quality of the training material and assessment exercises intact.
Exoexcellence can help professionals in learning and understand popular international standards with practical exercises and real case studies. Some of the standards in which the Exoexcellence team can help are ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 31000, IEC 27001, ISO 13485, ISO 22301, SA 8000, IATF 16949, and other management system standards.