RAPS-Ontario & SGS Medical Device Symposium

This comprehensive program covers both pre- and post-market risk assessment strategies, with a special emphasis on software, artificial intelligence (AI), and cybersecurity considerations. Participants will delve into key concepts, methodologies, and tools for identifying, evaluating, and mitigating risks throughout the device lifecycle. Through interactive sessions, case studies, and practical exercises, attendees will gain practical insights and best practices to ensure compliance with MDR requirements while optimizing product safety and effectiveness.

Join us for an intensive two-day training course that offers a comprehensive deep dive into the Medical Device Single Audit Program (MDSAP) from an auditor’s perspective. This meticulously designed course aims to provide participants with a robust understanding of the MDSAP framework, which is essential for ensuring compliance with international regulatory requirements.During this course, participants will be guided through the intricate details of the MDSAP program, including its grading system, timing, and reporting procedures. The training will cover the step-by-step audit process sequence, providing insights into each stage of the audit. Special emphasis will be placed on auditing techniques based on ISO 19011:2018, preparing attendees to apply these methodologies effectively in their audit practices.Participants will also gain a thorough understanding of the various regulations under the MDSAP program, which encompass multiple jurisdictions including the United States, Canada, Brazil, Japan, and Australia. This course will provide an overview of the specific regulatory requirements of each participating country, ensuring that auditors are well-versed in the diverse regulatory landscapes they may encounter.

Join us for a comprehensive one-day training course on the Medical Device Single Audit Program (MDSAP). This course provides an essential introduction to MDSAP, ensuring that participants gain a thorough understanding of the program's structure and requirements. Throughout the day, attendees will delve into the background and objectives of MDSAP, explore the grading system, understand the detailed process steps, and learn about the auditing techniques based on ISO 19011. The course also covers the critical regulations under the MDSAP program and provides an overview of its chapters.