Training & Courses
Yallow Academy offer a comprehensive educational experience, covering everything from overall standards and regulations to specific processes and techniques. We are committed to providing in-depth knowledge and practical insights to professionals in the medical technology field. Our curriculum is designed to address the diverse needs of individuals and organizations, offering tailor-made courses that align with specific competency requirements.
Whether it’s understanding regulatory frameworks or mastering specialized processes, our training programs ensure a thorough understanding of the intricacies of medical device development. With a focus on delivering practical, industry-relevant knowledge, we empower individuals and teams to excel in the dynamic landscape of medical technology.
Our Courses
01.
ISO 13485
Gain a deep understanding of quality management systems specific to the medical device industry with our ISO 13485 certification training. Learn how to implement and maintain compliance with ISO 13485 requirements, ensuring the highest standards of quality and safety in medical device manufacturing.
02.
ISO 19011
Master the principles and practices of auditing management systems with our ISO 19011 auditor training. Develop the skills necessary to conduct effective internal and external audits, evaluate compliance with regulatory standards, and drive continuous improvement in your organization.
03.
ISO 14971
Learn the fundamentals of risk management for medical devices with our ISO 14971 training. Understand the principles of risk assessment, mitigation, and control, and gain the expertise to develop robust risk management processes that comply with regulatory requirements.
04.
MDR & IVDR
Learn the fundamentals of risk management for medical devices with our ISO 14971 training. Understand the principles of risk assessment, mitigation, and control, and gain the expertise to develop robust risk management processes that comply with regulatory requirements.
05.
CE Marking
Navigate the CE marking process with confidence with our CE marking training. Gain a comprehensive understanding of the European regulatory requirements for placing medical devices and IVDs on the market, and learn how to prepare documentation, conduct conformity assessments, and affix the CE mark.
06.
UDI
Master the implementation of Unique Device Identification (UDI) requirements with our UDI training. Learn how to create and manage UDI data, label medical devices and IVDs with UDI information, and ensure compliance with UDI regulations in key markets worldwide.