35 Courses delivered On Demand

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.

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.

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.

Gain the skills and credentials to kickstart a successful career and learn from the experts with this step-by-step

Unlock the secrets to navigating the intricate landscape of European medical device regulations with our comprehensive course. Designed for those who seek mastery in understanding and applying the latest EU standards, this course is your gateway to compliance excellence. Dive deep into the regulatory environment, where you'll explore the essential components that govern the medical device industry in Europe. Learn how to seamlessly integrate these regulations into your practice, ensuring your products meet the highest standards of safety and efficacy. Key Features: CPD Certified Free Certificate Developed by Specialist Lifetime Access Discover the nuances of reporting requirements and identification processes, critical for maintaining transparency and accountability. Our expertly curated content guides you through establishing a robust quality system, pivotal for regulatory success. Equip yourself with the knowledge to confidently manage regulatory submissions and navigate quality audits with ease. Join a community of like-minded professionals and elevate your regulatory expertise, ensuring your organisation stays ahead in the competitive medical device market. Enrol now to transform your approach to European medical device regulations and lead with confidence in a compliant and efficient manner. Course Curriculum 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 Learning Outcomes: Understand the core elements of European medical device regulations. Identify key components of EU Medical Device Regulation (MDR). Master reporting requirements and device identification processes. Implement quality systems in medical device regulation. Analyse essential EU MDR regulatory requirements. Navigate the complexities of EU medical device compliance. CPD 10 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Regulatory affairs specialists in the medical device industry. Quality assurance professionals in healthcare. Compliance officers in medical device companies. Medical device product managers. Legal advisors in healthcare regulation. Career path Regulatory Affairs Specialist Quality Assurance Manager Compliance Officer Medical Device Consultant Product Manager Regulatory Affairs Associate Certificates Digital certificate Digital certificate - Included Certificate of Completion Digital certificate - Included Will be downloadable when all lectures have been completed.

The Laboratory Technician is a wonderful learning opportunity for anyone who has a passion for this topic and is interested in enjoying a long career in the relevant industry. It's also for anyone who is already working in this field and looking to brush up their knowledge and boost their career with a recognised certification. This Laboratory Technician consists of several modules that take around 2 hours to complete. The course is accompanied by instructional videos, helpful illustrations, how-to instructions and advice. The course is offered online at a very affordable price. That gives you the ability to study at your own pace in the comfort of your home. You can access the modules from anywhere and from any device. Why choose this course Earn an e-certificate upon successful completion. Accessible, informative modules taught by expert instructors Study in your own time, at your own pace, through your computer tablet or mobile device Benefit from instant feedback through mock exams and multiple-choice assessments Get 24/7 help or advice from our email and live chat teams Full Tutor Support on Weekdays Course Design The course is delivered through our online learning platform, accessible through any internet-connected device. There are no formal deadlines or teaching schedules, meaning you are free to study the course at your own pace. You are taught through a combination of Video lessons Online study materials Mock exams Multiple-choice assessment Certification Upon successful completion of the course, you will be able to obtain your course completion PDF Certificate at £9.99. Print copy by post is also available at an additional cost of £15.99 and the same for PDF and printed transcripts. Course Content Module 01: Introduction to Laboratory Technician Module 01: Introduction to Laboratory Technician 00:10:00 Module 02: Role, Rules and Policies of Medical Laboratory Services Module 02: Role, Rules and Policies of Medical Laboratory Services 00:05:00 Module 03: Laboratory Equipments Module 03: Laboratory Equipments 00:15:00 Module 04: How to Work with Microscope Module 04: How to Work with Microscope 00:10:00 Module 05: Solutions Used in Medical Laboratory Module 05: Solutions Used in Medical Laboratory 00:05:00 Module 06: Sterilisation and Disinfection Module 06: Sterilisation and Disinfection 00:15:00 Module 07: How to Decontaminate Reusable Medical Devices Module 07: How to Decontaminate Reusable Medical Devices 00:20:00 Module 08: Laboratory Accidents and Safety Module 08: Laboratory Accidents and Safety 00:15:00 Module 09: Quality Assurance Module 09: Quality Assurance 00:05:00 Module 10: Standard Operating Procedures Module 10: Standard Operating Procedures 00:10:00 Module 11: Glossary Module 11: Glossary 00:05:00 Order your Certificates & Transcripts Order your Certificates & Transcripts 00:00:00 Frequently Asked Questions Are there any prerequisites for taking the course? There are no specific prerequisites for this course, nor are there any formal entry requirements. All you need is an internet connection, a good understanding of English and a passion for learning for this course. Can I access the course at any time, or is there a set schedule? You have the flexibility to access the course at any time that suits your schedule. Our courses are self-paced, allowing you to study at your own pace and convenience. How long will I have access to the course? For this course, you will have access to the course materials for 1 year only. This means you can review the content as often as you like within the year, even after you've completed the course. However, if you buy Lifetime Access for the course, you will be able to access the course for a lifetime. Is there a certificate of completion provided after completing the course? Yes, upon successfully completing the course, you will receive a certificate of completion. This certificate can be a valuable addition to your professional portfolio and can be shared on your various social networks. Can I switch courses or get a refund if I'm not satisfied with the course? We want you to have a positive learning experience. If you're not satisfied with the course, you can request a course transfer or refund within 14 days of the initial purchase. How do I track my progress in the course? Our platform provides tracking tools and progress indicators for each course. You can monitor your progress, completed lessons, and assessments through your learner dashboard for the course. What if I have technical issues or difficulties with the course? If you encounter technical issues or content-related difficulties with the course, our support team is available to assist you. You can reach out to them for prompt resolution.

Register on the Essentials of European Medical Device Regulations today and build the experience, skills and knowledge you need to enhance your professional development and work towards your dream job. Study this course through online learning and take the first steps towards a long-term career. The course consists of a number of easy to digest, in-depth modules, designed to provide you with a detailed, expert level of knowledge. Learn through a mixture of instructional video lessons and online study materials. Receive online tutor support as you study the course, to ensure you are supported every step of the way. Get an e-certificate as proof of your course completion. The Essentials of European Medical Device Regulations is incredibly great value and allows you to study at your own pace. Access the course modules from any internet-enabled device, including computers, tablet, and smartphones. The course is designed to increase your employability and equip you with everything you need to be a success. Enrol on the now and start learning instantly! What You Get With The Essentials of European Medical Device Regulations Receive a e-certificate upon successful completion of the course Get taught by experienced, professional instructors Study at a time and pace that suits your learning style Get instant feedback on assessments 24/7 help and advice via email or live chat Get full tutor support on weekdays (Monday to Friday) Course Design The course is delivered through our online learning platform, accessible through any internet-connected device. There are no formal deadlines or teaching schedules, meaning you are free to study the course at your own pace. You are taught through a combination of Video lessons Online study materials Certification Upon successful completion of the course, you will be able to obtain your course completion e-certificate free of cost. Print copy by post is also available at an additional cost of £9.99 and PDF Certificate at £4.99. Who Is This Course For: The course is ideal for those who already work in this sector or are an aspiring professional. This course is designed to enhance your expertise and boost your CV. Learn key skills and gain a professional qualification to prove your newly-acquired knowledge. Requirements: The online training is open to all students and has no formal entry requirements. To study the Essentials of European Medical Device Regulations, all your need is a passion for learning, a good understanding of English, numeracy, and IT skills. You must also be over the age of 16. Course Content Essentials of European Medical Device Regulations Module 1: Overview to European Regulations on Medical Devices Overview to European Regulations on Medical Devices 00:45:00 Module 2: Essential Components of EU MDR Essential Components of EU MDR 00:42:00 Module 3: Reporting Requirements and Identification Reporting Requirements and Identification 00:29:00 Module 4: Quality System in Medical Device Regulation Quality System in Medical Device Regulation 00:38:00 Frequently Asked Questions Are there any prerequisites for taking the course? There are no specific prerequisites for this course, nor are there any formal entry requirements. All you need is an internet connection, a good understanding of English and a passion for learning for this course. Can I access the course at any time, or is there a set schedule? You have the flexibility to access the course at any time that suits your schedule. Our courses are self-paced, allowing you to study at your own pace and convenience. How long will I have access to the course? For this course, you will have access to the course materials for 1 year only. This means you can review the content as often as you like within the year, even after you've completed the course. However, if you buy Lifetime Access for the course, you will be able to access the course for a lifetime. Is there a certificate of completion provided after completing the course? Yes, upon successfully completing the course, you will receive a certificate of completion. This certificate can be a valuable addition to your professional portfolio and can be shared on your various social networks. Can I switch courses or get a refund if I'm not satisfied with the course? We want you to have a positive learning experience. If you're not satisfied with the course, you can request a course transfer or refund within 14 days of the initial purchase. How do I track my progress in the course? Our platform provides tracking tools and progress indicators for each course. You can monitor your progress, completed lessons, and assessments through your learner dashboard for the course. What if I have technical issues or difficulties with the course? If you encounter technical issues or content-related difficulties with the course, our support team is available to assist you. You can reach out to them for prompt resolution.