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Category: ISO 13485

Categories:

PECB Certified ISO 13485 Lead Implementer – Training Course

Why should you attend?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.Who should attend?
  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members
Learning objectives
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
Educational approach
  • This training is based on both theory and best practices used in the implementation of a MDQMS
  • 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
PrerequisitesA fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Day 1: Introduction to ISO 13485 and initiation of a MDQMSDay 2: Plan the implementation of a MDQMSDay 3: Implementation of a MDQMSDay 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification auditDay 5: Certification Exam
After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential. For more information about ISO 13485 certifications and the PECB certification process, please refer to the Certification Rules and Policies.The requirements for PECB Implementer Certifications are:
CredentialExamProfessional experienceMDQMMS project experienceOther requirements
PECB Certified ISO 13485 Provisional ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentNoneNoneSigning the PECB Code of Ethics
PECB Certified ISO 13485 ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTwo Years: One year of work experience in Medical Devices Quality ManagementProject activities: a total of 200 hoursSigning the PECB Code of Ethics
PECB Certified ISO 13485 Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentFive Years: Two years of work experience in Medical Devices Quality ManagementProject activities: a total of 300 hoursSigning the PECB Code of Ethics
PECB Certified ISO 13485 Senior Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTen Years: Seven years of work experience in Medical Devices Quality ManagementProject activities: a total of 1,000 hoursSigning the PECB Code of Ethics
Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link: https://pecb.com/en/master-credentials.To be considered valid, these implementation activities should follow best implementation practices and include the following activities:Drafting a MDQMS planInitiating a MDQMS implementationImplementing a MDQMSMonitoring and managing a MDQMS implementation
After successfully completing the exam, you can apply for the credential shown on the table below.The certificate requirements for the ISO 13485 Foundation are:
DesignationExamProfessional experienceMS audit/assessment experienceMDQMMS project experienceOther requirements
PECB Certificate Holder in ISO 13485 FoundationPass the PECB ISO 13485 Foundation ExamNoneNoneNoneSigning the PECB Code of Ethics
  • Certification and examination fees are included in the price of the training course
  • Training material containing over 450 pages of information and practical examples will be distributed
  • An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free
Why should you attend?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.Who should attend?
  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members
Learning objectives
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices
Educational approach
  • This training is based on both theory and best practices used in the implementation of a MDQMS
  • 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
PrerequisitesA fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.
Day 1: Introduction to ISO 13485 and initiation of a MDQMSDay 2: Plan the implementation of a MDQMSDay 3: Implementation of a MDQMSDay 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification auditDay 5: Certification Exam
After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential. For more information about ISO 13485 certifications and the PECB certification process, please refer to the Certification Rules and Policies.The requirements for PECB Implementer Certifications are:
CredentialExamProfessional experienceMDQMMS project experienceOther requirements
PECB Certified ISO 13485 Provisional ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentNoneNoneSigning the PECB Code of Ethics
PECB Certified ISO 13485 ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTwo Years: One year of work experience in Medical Devices Quality ManagementProject activities: a total of 200 hoursSigning the PECB Code of Ethics
PECB Certified ISO 13485 Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentFive Years: Two years of work experience in Medical Devices Quality ManagementProject activities: a total of 300 hoursSigning the PECB Code of Ethics
PECB Certified ISO 13485 Senior Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTen Years: Seven years of work experience in Medical Devices Quality ManagementProject activities: a total of 1,000 hoursSigning the PECB Code of Ethics
Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link: https://pecb.com/en/master-credentials.To be considered valid, these implementation activities should follow best implementation practices and include the following activities:Drafting a MDQMS planInitiating a MDQMS implementationImplementing a MDQMSMonitoring and managing a MDQMS implementation
After successfully completing the exam, you can apply for the credential shown on the table below.The certificate requirements for the ISO 13485 Foundation are:
DesignationExamProfessional experienceMS audit/assessment experienceMDQMMS project experienceOther requirements
PECB Certificate Holder in ISO 13485 FoundationPass the PECB ISO 13485 Foundation ExamNoneNoneNoneSigning the PECB Code of Ethics
  • Certification and examination fees are included in the price of the training course
  • Training material containing over 450 pages of information and practical examples will be distributed
  • An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free
Ft275,022.34 Ft538,555.50Price range: Ft275,022.34 through Ft538,555.50
Enroll Now
Categories:

PECB Certified ISO 13485 Foundation – Training Course

Why should you attend?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.Who should attend?
  • Individuals involved in Medical Devices Quality Management
  • Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
  • 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
PrerequisitesNone
Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485Day 2: Medical Devices Quality Management System requirements and Certificate Exam
The exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)Domain 2: Medical Devices Quality Management System (MDQMS)For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
After successfully completing the exam, you can apply for the credential shown on the table below.The certificate requirements for the ISO 13485 Foundation are:
DesignationExamProfessional experienceMS audit/assessment experienceMDQMMS project experienceOther requirements
PECB Certificate Holder in ISO 13485 FoundationPass the PECB ISO 13485 Foundation ExamNoneNoneNoneSigning the PECB Code of Ethics
  • Certificate and examination fees are included in the price of the training course
  • Training material containing over 200 pages of information and practical examples will be distributed
  • An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free
Why should you attend?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.Who should attend?
  • Individuals involved in Medical Devices Quality Management
  • Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
  • 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
PrerequisitesNone
Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485Day 2: Medical Devices Quality Management System requirements and Certificate Exam
The exam fully meets the requirements of the PECB Examination and Certificate Programme. It covers the following competency domains:Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)Domain 2: Medical Devices Quality Management System (MDQMS)For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
After successfully completing the exam, you can apply for the credential shown on the table below.The certificate requirements for the ISO 13485 Foundation are:
DesignationExamProfessional experienceMS audit/assessment experienceMDQMMS project experienceOther requirements
PECB Certificate Holder in ISO 13485 FoundationPass the PECB ISO 13485 Foundation ExamNoneNoneNoneSigning the PECB Code of Ethics
  • Certificate and examination fees are included in the price of the training course
  • Training material containing over 200 pages of information and practical examples will be distributed
  • An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free
Ft169,944.18 Ft371,004.90Price range: Ft169,944.18 through Ft371,004.90
Enroll Now