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  ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement. After completing this course, you can sit for the exam and gain "Certified ISO 13485 Foundation' Certification. This Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.  About This Course   Learning Objectives Understand the elements and operations of a Medical Devices Quality Management System (MDQMS) Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Understand the approaches, methods and techniques used for the implementation and management of a MDQMS   Course Agenda Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485 Day 2: Medical Devices Quality Management System requirements and Certification Exam   Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 40 question, multiple choice exam on Day 2 of the course. The overall passing score is 70%, to be achieved within the 60 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.   Prerequisites   None What's Included?   Certification fees are included on the exam price Training material containing over 200 pages of information and practical examples will be distributed An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. Who Should Attend?   Individuals involved in Medical Devices Quality Management Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS) Individuals interested to pursue a career in Medical Devices Quality Management Accreditation Provided by   This course is Accredited by NACS and Administered by the IECB

  During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices. After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and gain the "Certified ISO 13485 Lead Implementer' Certificate. By holding this Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.  About This Course   Learning Objectives Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS Learn how to interpret the ISO 13485 requirements in the specific context of an organization Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices   Course Agenda Day 1: Introduction to ISO 13485 and initiation of a MDQMS Day 2: Plan the implementation of a MDQMS Day 3: Implementation of a MDQMS Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit, and the final exam. Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Prerequisites   A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles. What's Included?   Certification fees are included on the exam price Training material containing over 450 pages of information and practical examples will be distributed An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. In case of exam failure, you can retake the exam within 12 months for free Who Should Attend?   Managers or consultants involved in Medical Devices Quality Management Expert advisors seeking to master the implementation of a Medical Devices Quality Management System Individuals responsible for maintaining conformance with MDQMS requirements MDQMS team members Accreditation Provided by   This course is Accredited by NACS and Administered by the IECB

  During this training course, delegates will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process. Based on practical exercises, you will learn audit techniques and become competent to manage an audit program, audit team, communication with customers, and understand reporting requirements. After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain the "Certified ISO 13485 Lead Auditor' Certificate. By holding this Certificate, delegates can demonstrate that they have the competencies to audit organizations based on best practices. About This Course   Learning Outcomes   Review a Medical Devices Quality Management System based on ISO 13485 Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Understand an auditor's role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011 Learn how to lead an audit and audit team Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011   Course Agenda   Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485 Day 2: Audit principles, preparation and launching of an audit Day 3: On-site audit activities Day 4: Closing the audit and final exam.   Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final essay style exam, consisting of 12 questions, on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.   Prerequisites   An understanding of ISO 13485 requirements and knowledge of audit principles. What's Included?   Certification fees are included on the exam price Training material containing over 500 pages of information and practical examples will be distributed An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. Who Should Attend?   Auditors seeking to perform Medical Devices Quality Management System (MDQMS) certification audits Managers or consultants seeking to understand the Medical Devices Quality Management System audit requirements Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements Accreditation Provided by   This course is Accredited by NACS and Administered by the IECB

Duration 3 Days 18 CPD hours This course is intended for CliniciansUniversitiesHospitalsHealthcare ExecutivesEntrepreneursInvestors Overview Intro to blockchainMajor healthcare use cases of blockchainUnderstand different use cases of PEB that have already been implemented and encourage thought of new potential use cases. This course covers the intersection of healthcare and Blockchain. Training will include an overview of Blockchain, and uses for Blockchain in the healthcare industry, from medical records, to medical devices, insurance and more. Day 1 History of blockchain Blockchain 101 Decentralization/centralization Distributed ledger-private vs public Mining and consensus mechanisms Intro to healthcare on blockchain including Medical records FHIR, HL7 Day 2 Patient identity Value-based care and concepts (discuss outcome-based smart contracts) Medical devices, Wearables, IoT Patient adherence monitoring (with tokenized incentives-could also discuss with pt. empowerment), incentives, etc. Interoperability and other obstacles of implementation (industry inertia, large data sets, inherent resistance to change) Day 3 Supply chain (substandard and falsified medicines, divergence, compliance with DSCSA) Logistics Insurance (eligibility, reduced overhead, claims processing) Data sets AI technology (theoretical use cases) PT empowerment 1 & 2 (digital health wallet with access driven by smart contracts, monetizing data for sharing) Additional course details: Nexus Humans Blockchain for Healthcare Professionals training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Blockchain for Healthcare Professionals course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.

Course Overview This course provides a comprehensive introduction to European Medical Device Regulations (EU MDR), offering learners essential knowledge on the regulatory framework that governs medical devices in the European market. It covers the key components of the EU MDR, ensuring compliance with industry standards and regulations, and highlights the importance of quality systems and reporting requirements. Through this course, learners will gain a solid understanding of how to navigate and implement these regulations in their professional practice. This course is ideal for individuals seeking to expand their expertise in medical device regulation and is invaluable for those aiming to work within the medical device industry in Europe. Course Description The "Essentials of European Medical Device Regulations" course delves into the critical aspects of the EU MDR, including its foundational components, regulatory compliance, and the reporting and identification requirements for medical devices. Learners will explore the essential guidelines for ensuring quality systems are in place to maintain product safety and regulatory compliance. With a focus on practical scenarios and real-world applications, this course equips learners with the necessary skills to interpret and implement these regulations effectively. The course is designed for professionals looking to enhance their understanding of medical device regulations within the European market, offering in-depth insights into the key elements of the EU MDR and its impact on the industry. Course Modules Module 01: Overview to European Regulations on Medical Devices Module 02: Essential Components of EU MDR Module 03: Reporting Requirements and Identification Module 04: Quality System in Medical Device Regulation (See full curriculum) Who is this course for? Individuals seeking to understand European medical device regulations. Professionals aiming to enhance their regulatory compliance expertise. Beginners with an interest in the medical device industry. Regulatory professionals in the healthcare and life sciences sector. Career Path Regulatory Affairs Specialist Compliance Manager in the medical device industry Quality Assurance Manager Medical Device Consultant European Market Access Manager