Medical Devices courses

Join us for a comprehensive one-day training course providing an in-depth overview of the European Medical Device Regulation (EU MDR). Designed to equip medical device professionals with essential knowledge, this course covers key aspects of the EU MDR, including regulatory requirements, compliance strategies, and implementation challenges. Through engaging presentations, case studies, and discussions, participants will gain insights into the changes introduced by the EU MDR and learn how to navigate the regulatory landscape effectively.

Day 1: Overview of the EU MDRJoin us for a comprehensive one-day training course providing an in-depth overview of the European Medical Device Regulation (EU MDR). Designed to equip medical device professionals with essential knowledge, this course covers key aspects of the EU MDR, including regulatory requirements, compliance strategies, and implementation challenges. Through engaging presentations, case studies, and discussions, participants will gain insights into the changes introduced by the EU MDR and learn how to navigate the regulatory landscape effectively.Day 2: MDR Risk Management: Pre and Post MarketThis dynamic one-day training course focuses on mastering risk management under the MDR, covering both pre- and post-market risk assessment strategies. Special emphasis is placed on software, artificial intelligence (AI), and cybersecurity considerations. Participants will learn key concepts, methodologies, and tools for identifying, evaluating, and mitigating risks throughout the device lifecycle. Through interactive sessions and practical exercises, attendees will gain insights into ensuring compliance with MDR requirements while optimizing product safety and effectiveness.Day 3: MDR Clinical EvaluationThis intensive one-day training course provides comprehensive knowledge and skills for navigating clinical evaluation under the MDR. The program covers essential concepts, methodologies, and regulatory requirements for clinical investigation and post-market surveillance. Through interactive lectures, case studies, and exercises, attendees will learn how to conduct robust clinical evaluations, ensure compliance with MDR guidelines, and optimize post-market surveillance strategies. This course is ideal for those involved in product development, regulatory affairs, clinical research, or quality management.Day 4: MDR Documentation RequirementsThis comprehensive one-day training course focuses on the essential documentation requirements mandated by the MDR to ensure regulatory compliance and facilitate market access for medical devices. Participants will learn how to create, manage, and maintain documentation that adheres to MDR standards. The course covers the full spectrum of required documentation, including technical documentation, clinical evaluation reports, and post-market surveillance plans. Through interactive sessions and practical exercises, attendees will gain the knowledge and tools to navigate MDR documentation requirements confidently.Day 5: MDR Post Market Surveillance Requirements This one-day training course provides in-depth insights into the post-market surveillance (PMS) requirements outlined in Annex III of the MDR. Participants will learn how to establish a robust PMS system, conduct trend analysis, and implement corrective actions. Through interactive discussions and case studies, attendees will explore key concepts and best practices for managing post-market surveillance activities. This course equips participants with practical skills and strategies to enhance product safety and performance while meeting regulatory obligations

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.

Embark on a comprehensive journey into the world of clinical evaluation under the Medical Device Regulation (MDR) with our intensive one-day training course. Designed to equip participants with the knowledge and skills necessary to navigate the complexities of clinical investigation and post-market surveillance lite, this program covers essential concepts, methodologies, and regulatory requirements. Through interactive lectures, case studies, and practical exercises, attendees will gain insights into conducting robust clinical evaluations, ensuring compliance with MDR guidelines, and optimizing post-market surveillance strategies. Whether you're involved in product development, regulatory affairs, clinical research, or quality management, this course provides invaluable guidance to enhance your proficiency in MDR clinical evaluation practices.

Unlock the intricacies of documentation compliance under the Medical Device Regulation (MDR) with our comprehensive one-day training course. Delve into the essential documentation requirements mandated by MDR to ensure regulatory compliance and facilitate market access for medical devices. Through interactive sessions and practical exercises, participants will gain insights into creating, managing, and maintaining documentation that adheres to MDR standards. From technical documentation to clinical evaluation reports and post-market surveillance plans, this course covers the full spectrum of documentation needed for successful MDR compliance. Whether you're a regulatory affairs specialist, quality assurance manager, or involved in product development, this course equips you with the knowledge and tools to navigate the complex landscape of MDR documentation requirements confidently.

Embark on a comprehensive journey through the intricacies of post-market surveillance (PMS) requirements outlined in Annex III of the EU Medical Device Regulation (MDR) with our one-day training course. Designed to provide in-depth insights into the regulatory landscape governing post-market surveillance activities, this course equips participants with the knowledge and tools needed to navigate Annex III compliance effectively. From establishing a robust PMS system to conducting trend analysis and implementing corrective actions, participants will explore key concepts and best practices essential for ensuring ongoing compliance with MDR regulations. Through interactive discussions and case studies, attendees will gain practical skills and strategies for managing post-market surveillance activities to enhance product safety and performance while meeting regulatory obligations.

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.

This course is designed to provide participants with a thorough understanding of the ISO 13485:2016 standard, which specifies requirements for a quality management system (QMS) for the design and manufacture of medical devices. Participants will gain detailed insights into the structure and key requirements of ISO 13485:2016, understanding how to implement and maintain an effective QMS in a medical device manufacturing environment. The course blends formal instruction with practical exercises and discussions, ensuring a robust understanding of the standard and its application. SGS North America is certified by Exemplar Global as a training provider. Participants who successfully complete this course and achieve Competency through the course exam will receive a Certificate of Attainment for the following Exemplar Global knowledge competency unit:MD - Medical Devices Quality Management SystemsImportant Notes:We recommend that you turn your camera on during the course to enhance engagement and participation.For the course exam, all learners are required to keep their camera on for the entire duration of the exam.Please bring a valid photo ID (e.g., driver’s license, passport, or work badge) to class for identity verification purposes prior to the exam.Enrollment and attendance in this course indicate participant agreement for SGS Academy NAM to share enrollment information (e.g., participant name, email address, Competency Units attempted, TPECS examination results, etc.) with Exemplar Global. This information will not be shared with any third party (e.g., employer) without the participant’s written consent, unless required by law.

This intensive course is designed to provide participants with an in-depth understanding of the ISO 13485:2016 standard, focusing on the requirements for a medical device quality management system and the skills needed to lead audit teams effectively. The course combines comprehensive theoretical knowledge with practical auditing exercises, role-playing, and group discussions to ensure participants are well-equipped to conduct and lead internal and external audits.SGS North America is certified by Exemplar Global as a training provider. Participants who successfully complete this course and achieve Competency through the course exam will receive a Certificate of Attainment for the following Exemplar Global knowledge competency unit:MD - Medical Devices Quality Management SystemsAU – Auditing Management SystemsTL – Leading Management Systems Audit TeamsImportant Notes:We recommend that you turn your camera on during the course to enhance engagement and participation.For the course exam, all learners are required to keep their camera on for the entire duration of the exam.Please bring a valid photo ID (e.g., driver’s license, passport, or work badge) to class for identity verification purposes prior to the exam.Enrollment and attendance in this course indicate participant agreement for SGS Academy NAM to share enrollment information (e.g., participant name, email address, Competency Units attempted, TPECS examination results, etc.) with Exemplar Global. This information will not be shared with any third party (e.g., employer) without the participant’s written consent, unless required by law.

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485:2016 standard and the principles and practices of effective internal auditing according to ISO 19011:2026 guidelines. The course focuses on the application of ISO 13485:2016 requirements to ensure the quality and safety of medical devices, equipping auditors with the necessary skills to evaluate and improve their organization's quality management system. Participants will learn through a mix of formal tutorials, practical exercises, role-playing scenarios, and group discussions. SGS North America is certified by Exemplar Global as a training provider. Participants who successfully complete this course and achieve Competency through the course exam will receive a Certificate of Attainment for the following Exemplar Global knowledge competency unit:MD - Medical Devices Quality Management SystemsAU – Auditing Management SystemsImportant Notes:We recommend that you turn your camera on during the course to enhance engagement and participation.For the course exam, all learners are required to keep their camera on for the entire duration of the exam.Please bring a valid photo ID (e.g., driver’s license, passport, or work badge) to class for identity verification purposes prior to the exam.Enrollment and attendance in this course indicate participant agreement for SGS Academy NAM to share enrollment information (e.g., participant name, email address, Competency Units attempted, TPECS examination results, etc.) with Exemplar Global. This information will not be shared with any third party (e.g., employer) without the participant’s written consent, unless required by law.

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.