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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.

The purpose of this course is to equip learners with an understanding of the concept of Medical Device Quality Management Systems (MD QMS) and provides an overview of the purpose and requirements of ISO 13485:2016 as a tool for business improvement.The course covers the following content:Introduction and Structure of ISO 13485:2016, Clauses 1 to 3Clauses 4 (Quality Management System) and 5 (Management Responsibility)Clauses 6 (Resource Management) and 7 (Product Realisation)Clause 8 (Measurement Analysis and Improvement)

This course will provide learners with the knowledge and skills required to perform an internal audit, based on the Medical Devices Quality Management System (MD QMS) requirements of ISO 13485:2016.The course covers the following content:Introduction to Medical Device QMS and ISO 13485:2016; Clause 4 (Quality Management System), Clause 5 (Management Responsibility), Clause 6 (Resource Management), Clause 7 (Product Realisation) and Clause 8 (Measurement Analysis and Improvement)Audit: Definition, Principles and TypesRoles and Responsibilities of AuditorsPlanning and Preparation for the Audit, including On-site ActivitiesAudit Reporting and Follow-up

This training aims to familiarise participants with the Technical Documentation requirements of Medical Device Regulation (MDR) (EU) 2017/745, understand what Notified Bodies are looking for and why Technical Documentation needs to be ‘live’ documents which cover the full product life cycle.Course ContentIntroduction to Medical Device Regulation (MDR) and Technical DocumentationLooking at the definition of a medical device, understand what is impacting your Technical Documentation (TD) and why you need to keep your TD up to date, including general requirements associated with TD.Technical Documentation Content (Annex II)Understanding the requirements for Technical Documentation according to Annex II, trying to prepare documents that are new for your company and for a dedicated product, thinking about UDI-DI and basic UDI-DI, classification and associated rationale.Technical Documentation Content (Annex III)Learning to understand the requirements for Technical Documentation in Annex III, including post-market surveillance (PMS), the PMS Plan, PMS Report, and Periodic Safety Update Report (PSUR).Where to StartUnderstanding the importance of performing a gap analysis, conducting a Technical Documentation review, defining the TD structure by identifying areas to focus on and understanding the need for a transition plan.Case StudyTake part in an interactive session to support your understanding and be able to implement the knowledge and skills learnt during the course. This will include tasks on product classification, technical documentation, an MDR gap analysis, team competencies, GSPR matrix and clinical evaluation assessment.How Notified Bodies Assess Technical DocumentationBecome aware of specific areas that Notified Bodies will particularly focus on, understand the TD conformity assessment process described in Annex IX and learn about the assessment criteria that will be applied by Notified Bodies.On completion of this course Learners will be issued with a "Certificate of Attendance"

This course has been developed by SGS for the benefit of clients wishing to understand Medical Device Regulation (EU) 2017 – 745 and how to conduct an internal audit against its requirements.The course refers to the Medical Device Regulation that provides the context for internal audit. However, this course does not address Medical Device Regulation in detail.The course covers the following content:Overview of the Changes in MDR from MDDAuditing for Continual ImprovementAudit Definition, Types and PrinciplesRoles and Responsibilities of AuditorsThe Audit ProcessPreparing for the Internal AuditConducting the AuditAudit Review

The objective of this course is to provide leaners with knowledge and understanding of the additional requirements within the Medical Device Regulation (MDR) as well as of the current directives (MDD 93/42/EE) and ISO 13485:2016, including the terminology used and the certification requirements.

The objective of this course is to provide learners with the knowledge and skills required to perform an internal audit of part of a WHO GDP requirement as well as in accordance with ISO 19011:2018 as applicable and contribute to the continual improvement of the management systems.The course covers the following content:Introduction to GDPGDP basic requirements - hardwaresGDP basic requirements - softwaresValidation and qualificationOther good practicesAudit definitions, types and principlesRoles and responsibilities of auditorsPreparing for the internal audit, conducting the audit and audit review

Through a series of interactive sessions and hands-on workshops, become familiar with the World Health Organisation (WHO) Good Distribution Practices (GDP) for Pharmaceutical and Medical Device Products, in order to help you ensure compliance.

The purpose of this course is to equip learners with an understanding of the concept of Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices and provides an overview of the purpose and requirements of ISO 15378:2017 as a tool for business improvement.Course Content:Introduction to development of ISO 15378 and comparisons to ISO 9001Clause 3: Terms and definitionsClause 4: Context of OrganisationClause 5: LeadershipClause 6: PlanningClause 7: SupportClause 8: OperationClause 9: Performance EvaluationClause 10: ImprovementAnnex D Guidance on verification, qualification and validation requirements for primary packaging materialsOn completion of this course:Learners who are in attendance for the complete course will be issued with a ‘Certificate of Attendance’.Learners who pass the Quiz will be issued with a “Certificate of Successful Completion”

The purpose of this course is to equip learners with an understanding of the concept of Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices and provides an overview of the purpose and requirements of ISO 15378:2017 as a tool for business improvement.Course Content:Introduction to development of ISO 15378 and comparisons to ISO 9001Clause 3: Terms and definitionsClause 4: Context of OrganisationClause 5: LeadershipClause 6: PlanningClause 7: SupportClause 8: OperationClause 9: Performance EvaluationClause 10: ImprovementAnnex D Guidance on verification, qualification and validation requirements for primary packaging materialsAuditing for Continual ImprovementAudit Definition, Types and PrinciplesRoles and Responsibilities of AuditorsThe Audit ProcessPreparing for the Internal AuditConducting the AuditAudit Review

The purpose of this course is to familiarise learners with an overview of ISO 14971:2019 Medical Devices Application of risk management to medical devices and the differences between the 2012 and 2019 version.Course ContentIntroduction to ISO 14971:2019Planning for risk managementRisk analysis and evaluationRisk controlUsability and risk managementReport and post-production informationOn completion of this course Learners will be issued with a "Certificate of Attendance"