ISO 13485 Medical Devices Training for quality, compliance, and patient safety
Training in the medical devices sector is crucial to ensuring compliance with regulatory standards such as ISO 13485, enhancing product safety, improving quality management, and reducing risks, ultimately safeguarding patient health and maintaining trust in medical technologies.
Join our ISO 13485 training courses to ensure your organisation is compliant and you are maintaining the highest levels of quality and consistency in medical device manufacturing and distribution.
Medical Devices Training Courses
The aim of this course is to provide participants with an understanding of the quality and management system approach considering regulatory requirements and the requirements of ISO 13485:2016.
Duration: 1 Day, 09.00 – 17.00
Price: £495 +VAT
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
Course objecctives
The aim of this course is to provide participants with an understanding of the quality and management system approach considering regulatory requirements and the requirements of ISO 13485:2016.
- Understand the purpose and business benefits that can be achieved through the implementation of a Quality Management System
- Outline the structure and content of ISO 13485:2016 and some key differences from the ISO 9001 Quality Management System Standard
- Understand and interpret the requirements of ISO 13485:2016 and how the requirements assist the organisation in the operation of an effective Management System
- Lay a foundation of knowledge for quality management system implementation based on
ISO 13485:2016.
Course outcomes:
Upon completion of this course, participants should be able to:
- Understand the purpose and benefits of a quality management system
- Have a greater understanding of the structure, content and the intent of ISO 13485
- Explain the specific quality management-related requirements of ISO 13485
- Be familiar with the terms and definitions used
- Have a greater understanding of the concepts that underpin the content of the standard including systems and consideration of regulatory requirements
- Describe how the requirements are linked together to enable the organisation to achieve improved quality performance to meet customer and regulatory requirements
Book here: https://www.intertek.com/training/uk/#courses/BA070/
This course will help individuals understand the purpose of the quality management system, and the structure and content of ISO 13485, including its relationship with regulatory requirements such as the European Medical Devices Regulations (MDR) and the USA’s FDA Quality System Regulation (QSR). Participants will learn how audits can support the implementation and improvement of a management system and will develop audit skills and techniques to evaluate the conformance and effectiveness of processes.
Duration: 2 Day, 09.00 – 17.00
Price: £795 +VAT
Who should attend:
- internal quality management system auditors
- supplier auditors
- medical device professionals
- quality, audit, compliance, and/or regulatory affairs managers
- auditees preparing for certification audits
Course objectives:
- Learn the principles and practices of the quality management systems (QMS);
- Understand the interpretation of ISO 13485:2016 Standard, the quality management system and its application to Medical Devices;
- Develop skills in planning, preparing and performing value-added ISO 13485:2016 audits; preparing audit reports and conducting follow-up verification audits
Course outcomes:
By the end of this course ISO 13485 Internal Auditor training course, participants will be able to:
- explain the purpose, structure and content of ISO 13485:2016 Medical Devices
- outline the content of EU MDR and the USA FDA requirements for medical devices and their relationship with ISO 13485
- describe the roles and responsibilities of an auditor
- plan, conduct, report and follow up an internal audit in accordance with ISO 13485
- evaluate conformance of processes to ISO 13485 and related internal and regulatory requirements
Book here: https://www.intertek.com/training/uk/#courses/BA071/
