ISO 13485 Series – Medical Devices Quality Management Systems

4.83
(12 Ratings)

ISO 13485 Series – Medical Devices Quality Management Systems

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About Course

This courseware is a specialized program that addresses one of the critical areas in modern industries: medical device quality management system. It provides participants with comprehensive insights into ISO-13485:2016, the international standard for quality management systems for medical devices. It offers a unique opportunity for professionals to gain expertise in catering to the specific needs of the healthcare industries.

The courseware starts by introducing participants to the principles and requirements of ISO-13485:2016, emphasizing the importance of quality management in the development and manufacturing of medical devices. By the end of the program, learners are well-prepared to navigate the complex regulatory landscape, optimize operational processes and maintain the highest standards in medical device quality, ultimately contributing to improved patient outcomes and consumer protection.

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What Will You Learn?

  • Basic Philosophy of ISO Certification
  • Improved Operational Efficiency
  • Guidance through Various Frameworks
  • Different Processes Step by Step
  • Various ISO Standards
  • Benefits and Drawbacks

Course Content

ISO | Introduction

  • 01:08
  • A brief history behind the formation of ISO
    02:09
  • Name and Abbreviations
  • ISO Name & Logo
  • Organizational Structure of ISO
  • Membership
  • Financial Functioning of ISO

ISO | Benefits & Drawbacks

ISO | Certification

ISO | Conformity Assessment

ISO | Standards

ISO 13485 and related Standards – Medical Devices

ISO | Contribution for the Sustainable Development Goals (SDGs)

Other References

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Student Ratings & Reviews

4.8
Total 12 Ratings
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NP
3 days ago
One of the standout features of ISO 13485 is its alignment with regulatory requirements. Adhering to these standards significantly enhances regulatory compliance for medical device manufacturers, streamlining the process of obtaining approvals and ensuring adherence to global quality standards.
MK
5 days ago
The foundation laid by ISO 27000 is solid and well-structured. It begins with a clear understanding of information security principles, creating a robust base for organizations to build upon.
MA
2 weeks ago
It explores the regulatory requirements, risk management and documentation processes essential for ensuring compliance.
KB
2 weeks ago
This courseware is a valuable resource for professionals and organizations operating in the medical device industry.
VP
2 weeks ago
ISO 13485 promotes a culture of continuous improvement. The standards require organizations to regularly assess and reassess their quality management systems, fostering innovation and efficiency.
BR
1 month ago
The standards emphasize the importance of traceability and documentation, ensuring that every step in the production process is recorded and can be traced back. This not only helps in quality control but also proves invaluable in the event of audits or recalls, demonstrating transparency and accountability.
RK
2 months ago
The standards cover all aspects, from design and development to production and post-production activities, ensuring a holistic approach to quality management.
NL
2 months ago
ISO 13485 promotes a culture of continuous improvement, requiring organizations to regularly reassess their quality management systems.
MI
2 months ago
This ensures that organizations can confidently rely on their suppliers to meet the same high-quality standards, contributing to the overall integrity of the medical device ecosystem.
TR
2 months ago
It explores the regulatory requirements, risk management and documentation processes essential for ensuring compliance.
DB
3 months ago
This Courseware offers some guidance but lacks in-depth practical insights
SC
3 months ago
This courseware provides the requirements and best practices outlined in the ISO 13485 standard.
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