
ISO 13485
Medical Devices Quality Management System
ISO 13485
Medical Devices Quality Management System
As an international standard, ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from production to post-production, including decommissioning and disposal.

Benefits of Certification
Being an ISO 13485-certified professional imposes your determination to offer qualitative products and services to your company and/or clients. Attaining the necessary knowledge and skills to operate an ISO 13485 framework demonstrates your commitment to assisting your company to ensure continuous enhancement and better work processes.
It also indicates that you understand the importance of the safety and performance of medical devices and how a medical devices quality management system can assure just that, consequently leading to customer satisfaction. Similarly, it can introduce you to new opportunities, such as working for large companies that offer quality products and services. These companies will value your knowledge and expertise on this standard, while enabling you to maximize your earning potential.

By becoming an ISO 13485 certified professional, you will be able to:
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Increase the number of job opportunities
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Create new business connections
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Gain competitive advantage
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Increase effectiveness and lower costs
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Offer expertise on improving work processes
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Offer safer and more efficient medical devices
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Increase customer satisfaction
Lead Implementer
ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.
After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.
5
day
3
hours
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Day 1: Introduction to ISO 13485 and initiation of a MDQMS
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Day 2: Plan the implementation of a MDQMS
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Day 3: Implementation of a MDQMS
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Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit
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Day 5: Certification Exam
31
Target Audience
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Managers or consultants involved in Medical Devices Quality Management
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Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
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Individuals responsible for maintaining conformance with MDQMS requirements
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MDQMS team members
Learning objectives
By the end of this training course, the participant will:
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Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
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Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
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Learn how to interpret the ISO 13485 requirements in the specific context of an organization
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Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
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Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
Educational approach
The training course is participant-centred and contains:
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This training is based on both theory and best practices used in the implementation of a MDQMS
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Lecture sessions are illustrated with examples based on case studies
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Practical exercises are based on a case study which includes role playing and discussions
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Practice tests are similar to the Certification Exam
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Lead Auditor
ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.
5
day
N/A
This one-day training course is comprised of the following sections:
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Section 1: Training course objectives and structure
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Section 2: Standards and regulatory frameworks
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Section 3: Fundamental concepts and principles of quality management
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Section 4: An overview of ISO 9001 requirements — Clauses 4 to 10
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Section 5: Preparation for the certification audit
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Section 6: Closing of the training course
7
Target Audience
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Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits
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Managers or consultants seeking to master a Medical Devices Quality Management System audit process
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Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
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Technical experts seeking to prepare for a Medical Devices Quality Management System audit
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Expert advisors in Medical Devices Quality Management
Learning objectives
By the end of this training course, the participant will:
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Understand the operations of a Medical Devices Quality Management System based on ISO 13485
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Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
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Understand an auditor’s role to plan, lead and follow up on a management system audit by ISO 19011
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Learn how to lead an audit and audit team
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Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
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Acquire the competencies of an auditor to plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011
Educational approach
This training course is participant-centred and contains:
-
This training is based on both theory and best practices used in MDQMS audits
-
Lecture sessions are illustrated with examples based on case studies
-
Practical exercises are based on a case study which includes role-playing and discussions
-
Practice tests are similar to the Certification Exam
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Foundations
ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.
After completing this course, you can sit for the exam and apply for the “PECB Certificate Holder in ISO 13485 Foundation” certificate. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.
2
day
60
min
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Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
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Day 2: Medical Devices Quality Management System requirements and Certificate Exam
14
Target Audience
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Individuals involved in Medical Devices Quality Management
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Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
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Individuals interested to pursue a career in Medical Devices Quality Management
Learning objectives
-
Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
-
Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
-
Understand the approaches, methods and techniques used for the implementation and management of a MDQMS
Educational approach
-
Lecture sessions are illustrated with practical questions and examples
-
Practical exercises include examples and discussions
-
Practice tests are similar to the Certificate Exam
Prerequisites
There are no prerequisites to participate in this training course.