9 Educators providing Medical Device Development courses

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.

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

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

Overview This comprehensive course on European Medical Device Regulations will deepen your understanding on this topic. After successful completion of this course you can acquire the required skills in this sector. This European Medical Device Regulations comes with accredited certification, which will enhance your CV and make you worthy in the job market. So enrol in this course today to fast track your career ladder. How will I get my certificate? You may have to take a quiz or a written test online during or after the course. After successfully completing the course, you will be eligible for the certificate. Who is This course for? There is no experience or previous qualifications required for enrolment on this European Medical Device Regulations. It is available to all students, of all academic backgrounds. Requirements Our European Medical Device Regulations is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible with tablets and smartphones so you can access your course on Wi-Fi, 3G or 4G. There is no time limit for completing this course, it can be studied in your own time at your own pace. Career Path Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business & Management, Admin, Accountancy & Finance, Secretarial & PA, Teaching & Mentoring etc. Course Curriculum 1 sections • 4 lectures • 02:26:00 total length •Module 1: Overview to European Regulations on Medical Devices: 00:43:00 •Module 2: Essential Components of EU MDR: 00:40:00 •Module 3: Reporting Requirements and Identification: 00:27:00 •Module 4: Quality System in Medical Device Regulation: 00:36:00

Explore the intricacies of medical gas safety with our comprehensive course, 'Medical Gas Safety 101.' Master safety protocols, handling guidelines, and administration techniques to minimize risks in healthcare settings. Enhance your skills through hands-on simulations and gain the expertise needed to ensure patient safety and regulatory compliance. Join us for a transformative learning experience in the dynamic field of medical gas management

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 from Reed CIQ Approved 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 Essential Components of European Medical Device Regulations 1:45:07 1: Module 01: Overview to European Regulations on Medical Devices 33:17 2: Module 02: Essential Components of EU MDR 29:12 3: Module 03: Reporting Requirements and Identification 16:21 4: Module 04: Quality System in Medical Device Regulation 25:17 5: CPD Certificate - Free 01:00 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 Reed Courses Certificate of Completion Digital certificate - Included Will be downloadable when all lectures have been completed.

CPD accredited Level 3 Effective Auditing & Inspection course. Delivered online (Zoom) by a live tutor. Exam and Certificate fee included in the price.

Has the Computer System Validation Engineer left and you’ve been handed their responsibilities? Do the thoughts of your next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s 21 CFR Part 11, EU Annex 11 or other regulatory guidelines.

FOUR DAY ATTENDENCE AND TRAINING GUIDELINE: DAY ONE AND TWO - INTRODUCTION TO DERMAL FILLERS Day one Arrive and coffees (10.00) Registration, introduction and expectations (10.00-10.15) Structure of the training (10.15-10.30) Break (10.30-11.00) Lectures and interactive workshops / simulation (11.00 - 1230pm) Health and safety in the workplace Sharps injury and disposal The consultation process and prescriptions LUNCH (1300-1730) with a coffee break Basic life support Anaphylaxis - recognition and management Emergency kits - what it should contain and how to buy one Your doctors on call - how to contact our on call doctors for emergency advice How to use Hyalase safely - when to use it / recognise mechanism of action, how prescription in an emergency works and how to give the hyalase Practical and to include demonstration of Hyalase injection Our added benefits services for safety and convenience Day two Arrive and coffees (10.00) introduction and expectations (10.00-10.30) Structure of the training (10.30-11.00) Formal written examination covering key areas of THEORY for Dermal Filler injections: Anatomy, Physiology, Products and Complications. This will highlight early on if any important areas need to be covered in more detail for the students (11.00 - 1200) - Break for lunch - Practical session commences - (12.30 - 1800) - and in total on average we have scope for one model per 30 minutes on both of the Dermal filler days, so that’s a potential for 10 in total for a class size of maximum 4, which will give good hands on experience, as the way we train is to allow several people the opportunity to be involved with each patient - e.g. splitting into the phases of treatment, which allows the trainees to understand the concept of the treatment process. That would be - consultation, consent, marking up, readying equipment, performing the injection, providing advice and aftercare. DAY THREE AND FOUR BOTOX FOUNDATION COURSE Day three Arrive and coffees (10.00) introduction and expectations (10.00 – 10.30) Structure of the training (10.30 – 11.00) Formal written examination covering key areas of THEORY for Botox Application: Anatomy, Physiology, Products and Complications. This will highlight early on if any important areas need to be covered in more detail for the students (11.00 - 1200) - Break for lunch - Practical session commences - (12.30 - 1800) - and in total on average we have one model per 30 minutes on both the botox and days, so that’s a potential of 10 in total for a class size of 4, which will give good hands on experience, as the way we train is to allow several people the opportunity to be involved with each patient - e.g. splitting into the phases of treatment, which allows the trainees to understand the concept of the treatment process. That would be - consultation, consent, marking up, readying equipment, performing the injection, providing advice and aftercare. Day four Observed Treatment Process Examination The participants will be tested on the following key facets of safe practical care: Consultation process - rapport and understanding what the client wants Safe consent Marking and photographs Technical skill of injection Atercare provision and safety netting (eg if this happens do this / call me) 1 model will be provided for Botulinum (3 area) treatment and 1 - 2 clients for filler to ensure that each of the key anatomical areas covered are observed. Morning = Botulinum (0900 - 1230) Afternoon = Botulinum and Option Dermal fillers (1330 - 1630) Conclusion Candidates given session and refreshments and discussion regarding Case Studies and further support. (1700 - 1800)

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.