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Easy Learning with ISO 13485 Implementation Step by Step
Business > Industry
4 h
£14.99 £12.99
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Language: English

Master ISO 13485: A Practical Guide for Medical Device Professionals

What you will learn:

  • Implement ISO 13485 in your medical device organization
  • Build a robust Quality Management System (QMS)
  • Master risk management techniques specific to medical devices
  • Conduct effective internal audits and management reviews
  • Achieve and maintain ISO 13485 certification
  • Utilize downloadable templates for efficient QMS development
  • Learn from a real-world case study of ISO 13485 implementation
  • Understand and apply the PDCA cycle to continuous improvement
  • Develop compliant processes and procedures
  • Minimize risks and costs associated with ISO 13485 implementation

Description

Transform your medical device company's quality management system with our comprehensive ISO 13485 implementation course. This isn't just theory; it's a hands-on journey through the standard's requirements, guided by real-world examples and a detailed case study of a model medical device company. Learn how to navigate each step effectively, avoiding common pitfalls and building a robust, compliant system.

This course provides you with practical, actionable steps, supported by customizable templates designed to streamline your implementation. You'll gain the confidence to build your own Quality Management System (QMS) efficiently and cost-effectively. We walk you through critical areas, including risk assessment, process implementation, documentation, internal audits, and management review, providing you with the tools and knowledge you need for successful certification.

Benefit from the expertise of Dr. Amar, who is available to answer your questions and provide personalized guidance throughout the learning experience. This isn't just a course; it's your pathway to ISO 13485 compliance and a competitive edge in the medical device market. Downloadable templates, a real-world use case, and expert support empower you to master the standard, saving you time, money, and reducing compliance risks.

This course is designed for medical device professionals at all levels, from quality managers and engineers to executives and compliance officers. Regardless of your experience, this step-by-step approach will provide valuable insights and practical skills to improve your organization's quality system and accelerate compliance. Secure your future and ensure your company's success by enrolling today!

Curriculum

Introduction

This introductory section lays the groundwork for your ISO 13485 journey. You'll gain an understanding of Quality Management Systems, receive an overview of ISO 13485, and meet Medicore Inc., the model company that guides our practical case study. Lectures also cover the crucial PDCA cycle and provide foundational knowledge for success. Learn about introductory concepts of QMS, ISO 13485 Overview, the model company Medicore Inc., and the importance of the PDCA cycle.

Obtain Management Support

Securing buy-in from upper management is critical for successful ISO 13485 implementation. This short but essential section provides guidance on effectively obtaining the necessary support and commitment.

Identify Requirements

Before embarking on implementation, it's vital to clearly identify all relevant requirements. This section equips you with the methods to effectively pinpoint and analyze these needs.

Define the QMS scope

Defining your Quality Management System's scope is a key step. This section walks you through the process, ensuring clarity and precision in the process definition.

Write the QMS policy

Your QMS policy sets the tone and direction for your system. This section helps you craft a clear, concise, and effective policy statement that aligns with the ISO 13485 standard.

Implement processes and procedures

This section delves into the practical implementation of core processes and procedures, covering essential elements such as documentation, responsibilities, infrastructure, supplier management, and effective communication within your organization. You will learn how to create processes and procedures that ensure effectiveness and traceability, including topics such as documentation procedures, responsibilities and authorities, infrastructure, supplier and distributor management, and communication within the organization.

Product Realization Procedure

This section focuses on the product realization process, covering design and development inputs and outputs, design reviews, verification, validation, transfer, change control, and file management. It's a critical component of ensuring product quality and regulatory compliance. You will learn about the product realization procedure, including design and development inputs, outputs, review, verification, validation, transfer, and change controls.

Control of Production and Service Provision

This section covers the crucial aspects of controlling production and service provision, emphasizing cleanliness, process validation, product preservation, and monitoring & measurement techniques. These are key elements for consistently achieving high product quality and maintaining compliance.

Risk Assessment

Thorough risk assessment is paramount in medical device manufacturing. This section provides comprehensive guidance on conducting risk assessments, emphasizing both methodology and practical application, with different versions shown to illustrate successful implementations.

Training and Awareness

This section covers the importance of effective training and awareness programs to ensure your workforce understands and adheres to the QMS requirements.

Operate/Measure the QMS

This section covers the ongoing operation and monitoring of your QMS, highlighting essential steps to maintain its effectiveness and identify areas for improvement.

Internal Audit

This section offers a practical approach to conducting internal audits, covering planning, execution, reporting, corrective actions, and follow-up. You'll learn to effectively assess your QMS's effectiveness.

Management Review

Regular management review is vital for continuous improvement. This section guides you through conducting effective management reviews to ensure your QMS remains aligned with your business objectives and regulatory requirements.

Certification Process

This section provides an overview of the certification process, preparing you for the steps involved in obtaining ISO 13485 certification.

Conclusion

This concluding section summarizes key learnings and provides insights for continued success in maintaining your ISO 13485-compliant QMS.