Striving to demonstrate compliance with applicable requirements for your medical devices can be a challenge. With increasingly intricate regulations and the safety-critical nature of healthcare devices, it is vital to stay up to date with the latest standards and their requirements. CSA Group provides expert-led training to help you confidently navigate the European Regulatory Framework for Medical Device Regulation (MDR), and In Vitro Diagnostic Regulation (IVDR)
How Training Can Help
CSA Group’s MDR and IVDR regulatory training courses are intended for both newcomers and experienced professionals. Whether you are seeking to build foundational knowledge or deepen your knowledge, our courses can help your organization avoid costly revisions, optimize time-to-market, and gain confidence in your compliance approach.
Course Offerings
Basics of Biocompatibility in Medical Devices
Duration: 8 hours | Cost: $950 USD
Designed for professionals involved in material selection and biological evaluation, this course explores biocompatibility requirements, regulatory frameworks, and risk-based approaches to help protect patient safety. Participants will gain insights into ISO 10993, biological testing methods, and compliance strategies for medical device materials.
Overview of Sterilization for Medical Devices
Duration: 8 hours | Cost: $950 USD
This course provides a robust understanding of sterilization processes for medical devices, covering validation, regulatory requirements, and standards harmonized under MDR (EU 2017/745) and IVDR (EU 2017/746), which are also recognized under other regulatory frameworks. Participants will gain insights into sterilization methods, process validation, and compliance best practices.
Clinical Evaluation of Medical Devices According to Annex XIV of the MDR
Duration: 8 hours | Cost: $950 USD
Designed to help medical device professionals navigate MDR clinical evaluation requirements, this course covers key regulatory updates, clinical investigation planning, and post-market clinical follow-up (PMCF). Participants will learn how to establish a clinical evaluation plan and confirm compliance with Annex XIV of MDR 2017/745.
Human Factors and Usability Engineering in Medical Devices
Duration: 8 hours | Cost: $950 USD
This course explores the critical role of human factors and usability engineering in medical device design, verifying safe and effective user interactions. Participants will gain a deep understanding of ISO/IEC 62366, risk management principles, and usability testing to enhance device compliance and patient safety.
Medical Device Software Regulation
Duration: 8 hours | Cost: $950 USD
Focusing on ISO/IEC 62304 and key MDR/IVDR software requirements, this course provides an in-depth look at software lifecycle processes, risk management, and cybersecurity considerations. Participants will learn how to navigate complex regulatory landscapes to develop and maintain compliant medical device software.
Strategies for Vigilance and Post-Market Surveillance
Duration: 4 hours | Cost: $475 USD
This course covers post-market surveillance (PMS) and vigilance strategies required under MDR and IVDR, helping manufacturers establish proactive monitoring systems. Participants will learn how to develop PMS plans, report adverse events, and integrate compliance processes to enhance product safety and regulatory adherence.
Value & Benefits