ISO 13485 is designed for organizations involved in the medical device industry, ensuring that products meet regulatory requirements and customer needs.
Signox supports in the design, documentation, and implementation of QMS for medical devices, ensuring compliance with international standards.
ISO 13485: Foundation Course
Overview This course will teach you all that you need to understand the ISO 13485 standard and help you get familiarized with all the key concepts of a medical device QMS, like planning of product realization, design and development, validation processes, identification and traceability, management commitment, continual improvement, etc.
Course Benefits:
Understand the basics of ISO 13485
Learn the best practices for ISO 13485 compliance
Add new skills to your resume
Who Should Attend:
Team members involved in ISO 13485 implementation
Persons wanting to learn the basics of the ISO 13485 standard
Persons seeking to acquire new expertise and start a career in medical devices Quality Management Systems
Prerequisites:
There are no prerequisites to attend the ISO 13485 Foundations course
Training Duration:
The training Duration will vary based on the size, the complexity and the nature of the organization but a Minimum of 3 days for a class of not more than 25 participants.
ISO 13485: Lead Implementer Course
Overview This course will teach you how to become an independent consultant or practitioner for the implementation of a medical device QMS using the ISO 13485 standard, and how to build your consultant business.
Course Benefits
Improve your knowledge of ISO 13485 implementation techniques
Learn how to lead an ISO 13485 implementation project
Add new skills to your resume and expand your business
Who Should Attend:
Project and quality managers involved in ISO 13485 implementation
Novice consultants seeking to learn new expertise
Experienced consultants needing proof of their competence in ISO 13485 implementation
Prerequisites:
There are no prerequisites to attend this course.
Training Duration:
The training Duration will vary based on the size, the complexity and the nature of the organization but a Minimum of 5 days for a class of not more than 25 participants.
ISO 13485: Internal Auditor Course
Overview This course will teach you everything you need to know about ISO 13485 and how to perform an internal audit of your medical device Quality Management System (QMS). The course will help you get familiarized with all the key concepts of the medical device QMS and how to audit it, like planning of product realization, design and development, validation processes, identification and traceability, continual improvement, preparing the audit plan and audit checklist, etc.
Course Benefits
Understand the basics of ISO 13485
Improve your knowledge of auditing techniques
Add new skills to your resume
Who should attend:
Medical device quality managers
Persons responsible for conducting ISO 13485 internal audits
Compliance managers
Prerequisites:
ISO 13485 Foundation Course or Lead Implementer Course
Training Duration:
The training duration will vary based on the size, complexity, and nature of the organization, but a minimum of 3 days is required for a class of not more than 25 participants.
ISO 13485: Lead Auditor Course
Overview This Lead Auditor training allows you to become a certified Lead Auditor for ISO 13485. The course was created to help you start working as a National Auditor. After passing the exam, you will receive an ISO 13485 Lead Auditor certificate which proves your ability to perform certification audits and lead audit teams.
Course Benefits
Understand ISO 13485 Lead Auditor requirements
Improve your knowledge of auditing techniques
Learn how to lead audit teams
Add new skills to your resume and expand your business
Who should attend?
Novice consultants/auditors seeking to acquire new expertise and perform medical device QMS certification audits
Experienced consultants/auditors needing proof of their competence as ISO 13485 lead auditor
Quality managers that need to prepare for a medical device QMS audit
Prerequisites:
ISO 13485 Internal Auditor Course Training Duration:
The training duration will vary based on the size, complexity, and nature of the organization, but there should be a minimum of 5 days for a class of not more than 25 participants.