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This module provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA.

  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

Master the European Medical Device Regulations (EU MDR) with this comprehensive course. Gain the knowledge and skills you need to comply with the EU MDR and successfully bring your medical devices to market.

Explore the essentials of European Medical Device Regulations (EU MDR) with our comprehensive course. Gain insights into regulatory requirements, quality systems, and reporting protocols to ensure compliance in the healthcare industry.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Delve into the intricacies of European medical device regulatory frameworks with our comprehensive course, 'Essentials of European Medical Device Regulations.' This meticulously structured program provides an in-depth exploration of the critical components and legislative requirements necessary for navigating the complex landscape of medical device regulations in Europe. The first module introduces the foundational aspects of the European regulations, setting the stage for a deeper understanding of the legal and procedural elements that govern this sector. As the course progresses, participants will gain a thorough grasp of the Essential Components of EU MDR (Module 2), the pivotal aspects of Reporting Requirements and Identification (Module 3), and the integral role of Quality Systems in medical device regulation (Module 4). This course is meticulously designed to cater to the needs of professionals seeking a robust understanding of the regulatory environment, ensuring they are well-equipped to adhere to and implement these critical regulations. Learning Outcomes Acquire a solid foundation in the basic principles and framework of European regulations on medical devices. Understand the key elements of the EU Medical Device Regulation (MDR) and their application in the industry. Gain insights into the specific requirements for reporting and identification within the European regulatory context. Learn about the implementation and management of quality systems in compliance with medical device regulations. Develop the ability to interpret and apply regulatory guidelines in professional settings, enhancing compliance and operational efficiency. Why choose this Essentials of European Medical Device Regulations course? Unlimited access to the course for a lifetime. Opportunity to earn a certificate accredited by the CPD Quality Standards and CIQ after completing this course. Structured lesson planning in line with industry standards. Immerse yourself in innovative and captivating course materials and activities. Assessments designed to evaluate advanced cognitive abilities and skill proficiency. Flexibility to complete the Course at your own pace, on your own schedule. Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience. Unlock career resources for CV improvement, interview readiness, and job success. Who is this Essentials of European Medical Device Regulations course for? Professionals in the medical device industry seeking to deepen their understanding of EU regulations. Regulatory affairs specialists aiming to stay updated with the latest European legislative changes. Quality assurance personnel in the healthcare sector requiring knowledge of regulatory compliance. Medical device manufacturers and distributors needing to align their products with EU standards. Healthcare consultants and advisors focusing on European medical device regulatory frameworks. Career path Regulatory Affairs Manager: £40,000 - £60,000 Quality Assurance Specialist: £35,000 - £50,000 Compliance Officer: £30,000 - £45,000 Product Development Engineer: £33,000 - £55,000 Healthcare Consultant: £45,000 - £70,000 Medical Device Auditor: £37,000 - £53,000 Prerequisites This Essentials of European Medical Device Regulations does not require you to have any prior qualifications or experience. You can just enrol and start learning. This course was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Certification After studying the course materials, there will be a written assignment test which you can take at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £4.99 Original Hard Copy certificates need to be ordered at an additional cost of £8. Course Curriculum Module 1: Overview to European Regulations on Medical Devices Overview to European Regulations on Medical Devices 00:43:00 Module 2: Essential Components of EU MDR Essential Components of EU MDR 00:40:00 Module 3: Reporting Requirements and Identification Reporting Requirements and Identification 00:27:00 Module 4: Quality System in Medical Device Regulation Quality System in Medical Device Regulation 00:36:00

Learn the skills to provide essential care in emergency situations. This diploma will prepare you for a rewarding career in emergency care, helping people in need when they need it most.