Exploring ISO 14155:2020 – Navigating Clinical Investigations for Medical Devices
Welcome to a comprehensive course designed to unravel the intricacies of ISO 14155:2020—an international standard that forms the bedrock of good clinical practices in the realm of medical devices. As innovation in healthcare surges forward, ensuring the safety and performance of medical devices is of paramount importance. This course serves as your gateway to comprehending ISO 14155:2020 and delving deep into its key components, with a keen focus on critical elements such as the informed consent process, protocol development, quality control, compliance, safety reporting, and more.
A World of Clinical Investigations: Clinical investigations lie at the core of assessing the safety and performance of medical devices. ISO 14155:2020 sets the stage for rigorous practices that span from the inception of the investigation to its reporting. Throughout this course, you will gain a profound understanding of the nuances of clinical investigations, setting the foundation for regulatory compliance.
Deciphering ISO 14155:2020: At the heart of this course is ISO 14155:2020—a globally recognized standard that elevates the practice of clinical investigations. We will guide you through the standard’s key principles, highlighting its significance in ensuring ethical conduct, accurate recording, and meticulous reporting of clinical investigations involving human subjects.
Navigating Essential Elements: In our exploration of ISO 14155:2020, we shine a spotlight on crucial elements that shape the clinical investigation landscape. From understanding the informed consent process—a cornerstone of ethical research—to the development of comprehensive protocols and the development of CRFs (Case Report Forms), you will gain insights into practices that underpin robust clinical investigations.
Quality Control and Compliance: Ensuring the integrity of clinical investigations demands meticulous quality control and compliance measures. Throughout this course, we will delve into strategies to uphold the highest standards of quality, mitigate risks, and foster compliance with ISO 14155:2020.
From Investigational Device Handling to Reporting: The journey through ISO 14155:2020 takes us to investigational device handling, where you will learn how to manage devices ethically and effectively. Safety reporting—essential for monitoring and managing risks—will also be explored, alongside good documentation practices that form the backbone of rigorous clinical investigations.
Your Expert Guides: Guiding you through this comprehensive course are experts well-versed in ISO 14155:2020 and the intricate world of clinical investigations. Our team brings a wealth of experience in ensuring adherence to global standards while navigating the complexities of medical device research.
Opening Doors to Mastery: By the culmination of this course, you will be equipped with a thorough understanding of ISO 14155:2020, its key components, and the practices that drive successful clinical investigations. Armed with this knowledge, you will be well-prepared to embark on ethical, compliant, and effective medical device research endeavors.
We encourage active engagement, questions, and the sharing of insights. Together, we will navigate the landscape of clinical investigations, armed with ISO 14155:2020 as our compass, and chart a course toward safer, more effective medical devices that shape the future of healthcare.
Contact Us Now
- Name: Maria Nyåkern, Ph.D., Principal Advisor
- Phone: +34 697 77 13 47
- Email:maria@nyakern.com
- Website: www.nyakern.com
