ISO 13485:2016 Medical Device Quality Management Systems (MD QMS) Introduction Training Course

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"

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 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"