ISO 13485 Implementation Step by Step
ISO 13485 Implementation Step by Step, available at $64.99, has an average rating of 4.1, with 43 lectures, based on 11 reviews, and has 49 subscribers.
You will learn about Understand the key principles and requirements of ISO 13485 Learn how to implement ISO 13485 Gain insight into risk management in medical devices Enhance compliance with regulatory requirements This course is ideal for individuals who are Quality managers, quality assurance officers, and quality control personnel responsible for ensuring compliance with ISO 13485 and maintaining a robust quality management system. or Regulatory affairs professionals responsible for understanding and implementing regulatory requirements for medical devices and ensuring compliance with ISO 13485. or Engineers and designers involved in the design and development of medical devices, who need to understand the specific quality management requirements outlined in ISO 13485. or Compliance officers and internal auditors who are responsible for auditing and verifying adherence to ISO 13485 standards within their organization. or Individuals working in medical device manufacturing companies, suppliers, or contract manufacturers who need to ensure their operations align with ISO 13485 requirements. or Consultants and advisors who provide guidance and support to organizations in implementing ISO 13485 and establishing effective quality management systems for medical devices. or Individuals who wish to enhance their knowledge and skills in quality management systems for medical devices to advance their career prospects in the medical device industry. It is particularly useful for Quality managers, quality assurance officers, and quality control personnel responsible for ensuring compliance with ISO 13485 and maintaining a robust quality management system. or Regulatory affairs professionals responsible for understanding and implementing regulatory requirements for medical devices and ensuring compliance with ISO 13485. or Engineers and designers involved in the design and development of medical devices, who need to understand the specific quality management requirements outlined in ISO 13485. or Compliance officers and internal auditors who are responsible for auditing and verifying adherence to ISO 13485 standards within their organization. or Individuals working in medical device manufacturing companies, suppliers, or contract manufacturers who need to ensure their operations align with ISO 13485 requirements. or Consultants and advisors who provide guidance and support to organizations in implementing ISO 13485 and establishing effective quality management systems for medical devices. or Individuals who wish to enhance their knowledge and skills in quality management systems for medical devices to advance their career prospects in the medical device industry.
Enroll now: ISO 13485 Implementation Step by Step
Summary
Title: ISO 13485 Implementation Step by Step
Price: $64.99
Average Rating: 4.1
Number of Lectures: 43
Number of Published Lectures: 43
Number of Curriculum Items: 43
Number of Published Curriculum Objects: 43
Original Price: $19.99
Quality Status: approved
Status: Live
What You Will Learn
- Understand the key principles and requirements of ISO 13485
- Learn how to implement ISO 13485
- Gain insight into risk management in medical devices
- Enhance compliance with regulatory requirements
Who Should Attend
- Quality managers, quality assurance officers, and quality control personnel responsible for ensuring compliance with ISO 13485 and maintaining a robust quality management system.
- Regulatory affairs professionals responsible for understanding and implementing regulatory requirements for medical devices and ensuring compliance with ISO 13485.
- Engineers and designers involved in the design and development of medical devices, who need to understand the specific quality management requirements outlined in ISO 13485.
- Compliance officers and internal auditors who are responsible for auditing and verifying adherence to ISO 13485 standards within their organization.
- Individuals working in medical device manufacturing companies, suppliers, or contract manufacturers who need to ensure their operations align with ISO 13485 requirements.
- Consultants and advisors who provide guidance and support to organizations in implementing ISO 13485 and establishing effective quality management systems for medical devices.
- Individuals who wish to enhance their knowledge and skills in quality management systems for medical devices to advance their career prospects in the medical device industry.
Target Audiences
- Quality managers, quality assurance officers, and quality control personnel responsible for ensuring compliance with ISO 13485 and maintaining a robust quality management system.
- Regulatory affairs professionals responsible for understanding and implementing regulatory requirements for medical devices and ensuring compliance with ISO 13485.
- Engineers and designers involved in the design and development of medical devices, who need to understand the specific quality management requirements outlined in ISO 13485.
- Compliance officers and internal auditors who are responsible for auditing and verifying adherence to ISO 13485 standards within their organization.
- Individuals working in medical device manufacturing companies, suppliers, or contract manufacturers who need to ensure their operations align with ISO 13485 requirements.
- Consultants and advisors who provide guidance and support to organizations in implementing ISO 13485 and establishing effective quality management systems for medical devices.
- Individuals who wish to enhance their knowledge and skills in quality management systems for medical devices to advance their career prospects in the medical device industry.
The ISO 13485 implementation step by step course offers a unique and effective learning experience for professionals in the medical device industry. With a comprehensive approach, this course covers all the necessary steps to implement the ISO 13485 standard. It stands out from others by providing clear guidance and practical examples to navigate through each stage of implementation.
A notable feature of this course is the use of a model company as a use case. Participants will follow their journey of implementing ISO 13485, learning from their challenges and successes. This practical perspective enables a clear understanding of how the standard can be applied in real-world scenarios.
The course includes customizable templates that participants can utilize to create their own Quality Management System. These templates are designed to save valuable time and resources, ensuring an efficient implementation process.
Real-world examples are incorporated to showcase successful implementations by different organizations. Participants can draw insights from these examples and adapt them to suit their organization’s unique requirements.
Throughout the course, Dr. Amar is readily available to answer questions and provide guidance. The course emphasizes cost-effective implementation strategies, empowering participants to implement ISO 13485 efficiently and effectively.
In summary, this course equips learners with the necessary steps to implement ISO 13485 through a model company use case, real-world examples, and customizable templates. The focus is on supporting participants in achieving success, with dedicated assistance available when needed.
Course Curriculum
Chapter 1: Introduction
Lecture 1: Introduction
Lecture 2: Quality Management System
Lecture 3: ISO 13385 Overview
Lecture 4: Medicore Inc. The Use Case Company
Lecture 5: The PDCA Cycle
Chapter 2: Obtain Management Support
Lecture 1: Obtain Management Support
Chapter 3: Identify Requirements
Lecture 1: Identify Requirements
Chapter 4: Define the QMS scope
Lecture 1: Define the QMS scope
Chapter 5: Write the QMS policy
Lecture 1: Write the QMS policy
Chapter 6: Implement processes and procedures
Lecture 1: Implement Processes and Procedures
Lecture 2: Documentation Procedure
Lecture 3: Responsibilities and Authorities
Lecture 4: Infrastructure Procedure
Lecture 5: Suppliers and Distributors Procedure
Lecture 6: Communication Procedure
Chapter 7: Product Realization Procedure
Lecture 1: Product Realization Procedure
Lecture 2: Design and development inputs
Lecture 3: Design and Development Outputs
Lecture 4: Design and development review
Lecture 5: Design and Development Verification
Lecture 6: Design and development validation
Lecture 7: Design and Development Transfer
Lecture 8: Control of design and development changes
Lecture 9: Design and Development Files
Chapter 8: Control of Production and Service Provision
Lecture 1: Production and Service Provision
Lecture 2: Cleanliness of Product
Lecture 3: Validation of Processes for Production and Service Provision
Lecture 4: Preservation of Product
Lecture 5: Monitoring and Measurement of Product
Chapter 9: Risk Assessment
Lecture 1: Introduction to Risk Assessment
Lecture 2: How and Where to perform risk assessment
Lecture 3: Risk assessment in production V2.0
Chapter 10: Training and Awareness
Lecture 1: Training and Awareness
Chapter 11: Operate/Measure the QMS
Lecture 1: Operate/Measure the QMS
Chapter 12: Internal Audit
Lecture 1: Internal Audit Program
Lecture 2: Steps of Internal Audit
Lecture 3: Document Review & Audit Checklsit
Lecture 4: The Audit Plan & The Main Audit
Lecture 5: Reporting
Lecture 6: Corrective Actions & Follow-up
Chapter 13: Management Review
Lecture 1: Management Review
Chapter 14: Certification Process
Lecture 1: Certification Process
Chapter 15: Conclusion
Lecture 1: Conclusion
Instructors
-
Dr. Amar Massoud
Specialized in IT certfication trainings
Rating Distribution
- 1 stars: 0 votes
- 2 stars: 1 votes
- 3 stars: 2 votes
- 4 stars: 4 votes
- 5 stars: 4 votes
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