The top 17 Medical Devices courses you need to take

1. Medical Device Regulations

4.3

(100)

The medical device industry is growing rapidly, providing great opportunities for innovators, experts and entrepreneurs. This course will provide a detailed overview of the way in which new devices go from concept to product, providing you with a starting point to develop a deep understanding of this complex and fast-moving business space. We will cover all of the key components of bringing a new device to market, including: Paths to Market, including the 510K, PMA, HDE and other commonly used pathwaysClinical trials of medical devices, including IDE, submissions, records and reportingRisk management and quality in device developmentDuring this course we will also cover the publicly available information sources that will enable you to research device companies and understand their value. We will cover medical device databases that allow you to research marketed medical devices. We will cover clinical trial databases that allow you to research planned and ongoing trials of medical devices. Links to these freely available resources will be provided. This course will be a valuable resource for anyone interested in developing their basic knowledge of the medical device industry. For students and recent graduates in medical device engineering, this course will help you develop a knowledge of the industry and the regulatory steps that companies use to bring new innovations to market. For project managers, this course can help you to learn about this industry and equip you to manage medical device development projects. For professionals working in related fields, this course will provide an overview of the medical device industry...

2. Medical Device Development

4.2

(86)

This course will provide a detailed overview of medical device development from a realistic industrial  perspective using recorded lectures and slides which are all provided.  The processes used in corporations  to conceive and develop devices will be explored from a research, regulatory, clinical, QA/QC, marketing, engineering, and legal perspective under the umbrella of project management techniques.  Material will be presented as an aide to students who wish to decide on careers in either industry or academia.      For students or newly minted engineers that find themselves participating on project teams, this course will give them basic knowledge needed to function.      For Professors interested in making a change or learning more about their commercial counterparts, this course will bridge the knowledge gap and convey an understanding of what accommodations can be made to do that.      Anyone that needs an overview of the major roles found in device companies can benefit from this course...

3. Advanced Medical Device Development

4.5

(59)

This course is a continuation of Medical Device Development. Topics cover the primary events that occur from just before "design freeze of a medical device up through clinical evaluation and commercial launch. Significant emphasis is placed on Quality Systems and Manufacturing, with attention to regulatory and legal compliance as well as design concepts. The course begins by supplementing already existing US Regulatory knowledge with the basics of medical device regulation in the EU, specifically the Medical Device Regulation (MDR) and In Vitro Devices Regulation (IVDR).  This discussion then carries on to post-design activities, such as finishing construction of the Design History File and the first steps of commercialization.  Once the device has entered to market, changes are often required to the manufacturing process and the device itself.  Methods for enacting these changes and validating the resulting new processes are discussed. Finally the course ends with a deep discussion on post-market activities in relation to Product Management and clinical trials.  The necessary regulations for running human studies are covered in detail, along with a description of the Product Manager's role in making the activities come together...

4. Medical Device Regulation (MDR): Intro for Device Designers

4.4

(520)

Welcome to this short video series introducing the European Union's Medical Device Regulation (MDR). If you're involved in the design and development of medical devices and are looking to get up to speed on this current regulation hopefully you'll find this series useful. What's InWe run through a lot of the topics covered in the MDR starting at what specifically count as medical devices, what rules govern the marketing claims which can be made about them and how development for the MDR relates to international harmonised standards. We introduce a lot of the obligations placed on us as designers and manufacturers including technical documentation, traceability, risk management and a lot of other content I hope you'll find useful. We also signpost where you can find more detail on each topic as we go along. What outIn this series, we focus more on aspects of the MDR relevant to design and development of devices in preparation for sale rather than, distribution, post market requirements, or the requirements placed on notified bodies which are also covered in the MDR. Who's it for?Whether you're just getting started in the medical device industry or looking to get up to date on this latest regulation, hopefully you will find this series useful and it will help take your learning to the next level...

5. Mastering Product Marketing for Medical Devices

3.9

(66)

Are you interested in working with products that can improve, and sometimes even save people's lives?  All while being paid a high salary to do so?  Then a career in marketing medical devices may be for you.  This course will teach you everything you need to know about being an effective product marketer in the medical device industry...

6. Applied ISO14971 Medical Device Risk Management

4.5

(637)

The internationally accepted standard guideline for medical device risk management is the ISO 14971 standard. This 2.4-hour long course is based on the current ISO 14971:2007 edition. It has been designed to provide a concise but complete knowledge of medical device risk management to supplement readings of the 80-page standard and to initiate those who are new to the medical device industry. More focus has been given to explaining the use of key tools such as the Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis (FTA) to enable immediate application in ISO 14971 projects. This course offers a systematic methodology to comprehend medical device risk management and connects the vital elements of risk management methodologies for a more efficient application of principles. It also provides guidelines on how to conduct productive meetings to construct medical device risk profiles. Why is this course essential to take? Performing risk management is a regulatory obligation and is the underpinning tool for assessing medical device safety. Risk management is part of the design input requirements during product design & development. This means that risk control and hazard reduction measures must be included as key considerations in the final medical device design, as well as in verification and validation studies. Risk evaluation should occur continuously throughout the production and post-production processes. An organised and methodical approach to understanding and applying the ISO14971 principles This ISO 14971 course takes a business approach to medical device risk management. Business tools such as project management techniques are recommended to establish risk management team structures. This ensures an organisation-wide support and commitment to comply with the ISO 14971 requirements. The Failure Mode and Effects Analysis (FMEA) and the Fault-Tree Analysis are discussed in greater detail to clearly explain their applicability to medical device risk management. Course materials and resources provided 7 practice workshopsRisk management plan templateQuantitative risk/benefit analysis technical reportFMEA worksheet in MS Excel formatAAMI White Paper: Risk Principles and Medical Devices...

7. EU Medical Device Regulatory Affairs explained Simply

4.3

(391)

Each lecture is explained in simple format. If the student takes each lecture step by step, they will understand how a company gains permission to manufacture a medical device which will be allowed to be sold in Europe. This module is ideal for a person who wants to work in medical device regulation, who wants to be involved in a medical device start up or who wants to be involved in the medical device industry either in operations, quality, engineering, marketing and research/development. If you are a student who wants to understand the rules that govern the sale of medical devices in the European Union Market place this course is perfect for you. If you are a medical device manufacturer outside the European Union and would like to sell your product in Europe this course is ideal for you. You will understand how important the ISO 13485 2016 standard is to gain market approval. The following topics will be covered:´Difference between Regulation and a Directive.´Steps required to get permission to manufacture and sell a medical device in Europe.´Competent authority´Notified body.´MDD 90/385/EEC Active Implantable Medical Device Directive.´MDD 93/42/EEC Medical Device Directive.´MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices.´MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).´CE Marking approval process.´Classification of medical device. Including the MDR 2017 745 classification. ´ISO 13485 2016´Other players the Manufacturer, the Authorized representative and the EFTA. Each lecture has a quiz that will enable students to understand the learner outcomesBrexit understand the impact to the European Union regulation. Understand the transitional time lines from the directives to the medical device regulation...

8. Practical Regulatory Affairs 2020 - European Medical Devices

4.5

(527)

The EU Medical Device Regulations (MDR 2017/745) represents the biggest change to medical device legislation in Europe for over 20 years. The MDR affects all medical device manufacturers (and others!) wanting to sell devices in the EU. This course focuses on the practical application of the MDR, using real-world examples and exercises to help you understand not only what the Regulations mean, but what we need to do to comply with them. Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to transition to the MDR...

9. Medical Device Sales 101: Masterclass + ADDITIONAL CONTENT

4.4

(69)

The Academy for Medical Device Sales has provided hundreds of individuals with online training to help them understand the medical device sales industry and help them nail that next job interview. Currently the Academy for Medical Device Sales focuses on teaching the fundamentals of the med device industry such as:1) Learning and mastering the basics of medical sales2) Attributes that make a good rep, and how to make a good rep GREAT!3) How to navigate one of the most complex selling environments in the world. 4) How to bring an immediate positive impact once you are hired.5) Basic knowledge about important topics such as HIPPA and the Sunshine Act. 6) Credentialing requirements and much more... The course curators have a combined 30 years of med device selling experience with both companies large and small. Our product knowledge includes everything from commodity products, implantable hardware, biologics, and capital. Our selling points include the operating room, surgery centers, materials management, sterile processing, c-suite, and direct to physicians. Our experience will become your knowledge!...

10. ISO 13485 Demystified - Medical Devices' QMS 360° Insights

4

(648)

Welcome to ISO 13485:2016 which is a training course that comprehensively explores Quality Management Systems for Medical Devices! This in-depth course is designed to provide you with a thorough understanding of the ISO 13485:2016 standard and its application in the context of medical device manufacturing and quality assurance. As the medical device industry continues to evolve, adherence to stringent quality standards is paramount. ISO 13485:2016 sets the benchmark for Quality Management Systems (QMS) specifically tailored to medical devices, ensuring their safety, efficacy, and compliance with regulatory requirements. Whether you're an industry professional, a quality manager, a regulatory affairs specialist, or someone new to the field, this course will equip you with the knowledge and skills needed to excel in the dynamic and critical realm of medical device manufacturing. What you'll learn: Gain a comprehensive overview of the ISO 13485:2016 standard, including its structure, scope, and key requirements. Understand the significance of ISO 13485 certification and its role in ensuring product quality and regulatory compliance. Explore the principles of quality management and their application in the medical device industry. Dive deep into each section of the ISO 13485 standard, uncovering essential concepts and best practices. Learn how to establish and implement a robust Quality Management System tailored to medical device manufacturing. Discover effective techniques for risk management, process validation, and documentation within the context of ISO 13485. Navigate the complexities of supplier management, traceability, and post-market surveillance to maintain product quality and safety. Stay up-to-date with recent developments, trends, and regulatory changes impacting the medical device industry. Why take this course: Expert Instruction: Learn from seasoned industry professionals with extensive experience in medical device manufacturing and quality management. Practical Insights: Acquire practical knowledge and real-world insights to implement ISO 13485 principles within your organization effectively. Interactive Learning: Engage in interactive quizzes, case studies, and practical exercises to reinforce your understanding. Career Enhancement: Boost your career prospects by adding ISO 13485 expertise to your skill set, making you a valuable asset to medical device companies worldwide. Self-Paced Convenience: Access course content anytime, anywhere, and progress at your own pace. Certificate of Completion: Earn a prestigious Udemy certificate upon successfully finishing the course, showcasing your newfound expertise. Embark on this educational journey and empower yourself with the expertise needed to navigate the intricate landscape of Quality Management Systems for medical devices. Enroll today and become a driving force for quality, compliance, and innovation in the medical device industry...

11. Practical Regulatory Affairs 2020 - US FDA Medical Devices

4.4

(726)

From the authors of the leading EU Medical Device Regulations course on Udemy, we now present Practical Regulatory Affairs 2020 for US FDA Medical Devices. The US is one of the worlds leading medical device markets, with a unique regulatory framework. Being able to navigate the US regulatory landscape is a crucial skill for anyone interested in working in regulatory affairs, or anyone looking to bring a device to market in the US. This course focuses on the practical application of regulatory tools and pathways available through the US FDA, using real-world examples and exercises to help you understand not only the regulations themselves, but how to effectively comply with them. Wherever possible, we provide you with relevant links and information from the FDA itself to guide your understanding in each module. Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to enter the US market...

12. Medical Devices Quality Management System - ISO 13485:2016

4.2

(631)

The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies. Having a proper QMS in place is essential for medical device-related companies. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide. With this need for implementation, comes a need for understanding of the requirements. The purpose of this course is to clarify the application of ISO 13485:2016 standards for medical device companies and development of the medical device. In this course, we will walk through the ISO 13485:2016 standard to: Clarify on the conceptsShow how it relates to business processesElaborate on the practical applicationYou can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations. Furthermore, you can begin preparing your relevant set of documents (Quality Manual, SOPs, etc) for immediate implementation of your SOPs. Understand and implement a best-practice Quality Management System as per requirements for the medical industry. Get the information you need to design, coordinate and improve your company's QMS as per ISO 13485:2016...

13. Medical Device Regulation 2017/745 EU regulatory affairs.

4.3

(764)

This Course is broken into nine sections. The objective of the course is to explain the medical device regulation 2017/745 in simple terms: Section 1 Introduction. Introduction to the Medical device regulation 2017 745. Why was there a change from the directive to the MDR 2017 745?The timelines for the transition of the MDR 2017 745. How the COVID pandemic has impact these timelinesSection 2 Economic Operator. Economic Operators. Who are they?Economic Operator. The European Authorised representative. Explain their obligation. Economic Operator. The Distributor. Explain their obligation. Economic Operator. The Importer. Explain their obligation. Economic Operator. The Manufacturer. Explain their obligation. Economic Operator. The Procedure pack & Systems Provider. Explain their obligation. When does an Economic operator obligation change?Explain the obligation of a person responsible for regulatory complianceSection 3 EUDAMEDIntroduction to what EUDAMED is. Understand what is meant by the actor registration. The timelines for the transition of EUDAMED systemSection 4 Unique Device Identification and registrationUDI Introduction Part 1. What is it? Why is it needed?UDI Part 2. Understand the unique device identification carrier. UDI Part 3. Understand who the current accredited organisations are that can create Unique Device identification carrier standards. UDI timelines. When the UDI carrier needs to be attached to the packaging and devices. Section 5 Classification of medical devicesClassification of medical devices Introduction. Qualification of medical devices. Determine if the manufacturer is making a medical device. Understand medical device definitions. This will help the student how to classify a medical device. Rules of medical device classification. Understand the implementation of the rules. MDR apply medical device rules. Section 6 Conformity assessmentExplain the Conformity assessment path for a Class I medical deviceExplain the conformity assessment path for a class I s, I m & I r medical device. Explain the conformity assessment path for a Class II a medical device. Explain the conformity assessment path for a Class II b medical device. Explain the conformity assessment path for a Class III medical deviceSection 7 Sufficient Clinical dataThe General Safety and Performance Requirements. The Intended purpose. Sufficient clinical Data. Clinical Evaluation. Post Market Clinical Follow up (PMCF). Section 8 Post Market Surveillance. Post Market Surveillance. Post-market surveillance report & Periodic safety update. Post-market vigilance. Analysis of vigilance data. Role of Competent Authority & European Commission within Market SurveillanceSection 9 Other ItemsMedical device coordination groupBrexitSwizterland Mutual Recognition AgreementTurkey and EFTA agreement with the EU. Common Specifications The Rolling plan. The benefits of the course will be: Save you time. Really understand regulation in simple terms. Help you prioritizes work to prepare for the MDR 2017 745 timelines. Understand why regulation was introduced. Know your obligation to the MDR 2017 745. Know the obligation to EUDAMED and the timelines. Examples of how Unique Device Identification carriers are created. Worked examples how medical devices are classified. Know the conformity assessment route to take for each medical device. Know what sufficient clinical data to collect to be compliant. Understand the market surveillance requirements to allow the medical device to stay in the market place.  Understand the UK and EU manufacturers responsibility post Brexit.  Understand Turkey and the EFTA (Switzerland, Liechtenstein, Norway and Iceland) manufacturers responsibility regarding the MDR 2017 745...

14. Medical Device Process Validation. ISO 13485. IQ OQ PQ.

4.4

(900)

This Course is broken into six sections. The objective of the course is to explain process validation in simple terms: Section 1 will give an introduction to process validation and explain why we need it. We will discuss the steps we take to decide if we need to validate. The course focuses on medical device process validation. We will explain the regulation governing process validation within the medical device industry. This will explain how ISO 13485, the FDA Quality system regulation (QSR) and the FDA 21 CFR 820 fit into regulation that governs process validation. Please remember the course explains process validation so it can benefit people interested in manufacturing in any industry. This section will explain the 3 different types of validation. In section 2 we will explain how process validation is performed. We will explain what the user requirement specification is. We will explain design qualification. Install qualification will be explained which contains the factory acceptance test and the site acceptance test. We will explain what an operational qualification is. We will demonstrate an operational qualification. We will explain what a performance qualification is. Section 3 will explain what is meant by process capability and how it relates to process validation. We will understand the process capability ratio and the process capability index. We will understand the process model, control limits and action limits. We will understand the Design of experiments and how this is used in the operational qualification part of process validation. Section 4 Risk ManagementWe will point out where risk management is required within the medical device regulation. We will explain how risk management fits into the validation process. We will summarise how the ISO standard 14971 is utilised and therefore how risk management is applied. Section 5 Process Validation DocumentationIn this section we will understand the documentation which needs to be created in order to complete process validation. We will explain terms as follows:· Process Validation Documentation.· Validation Master Plan.· Validation Plan.· Validation Change control.· Calibration within Process Validation.· Preventive Maintenance within the validation process.· Validation Summary ReportSection 6 will explain in chronological steps how regulation developed for the life science industry in the U. S. We will study this and understand how the regulation developed to include process validation. The course will be of great benefit to anybody that really wants to understand process validation in simple terms. It can be a very useful training package for the following disciplines:· Operations.· People managers.· Manufacturing Engineers.· Process Engineers.· Quality Engineers.· Regulatory Affairs.· Research and development Engineers.· Process and development Engineers.· Students who need to really understand process validation in simple terms.· Entrepreneurs or small medium start-up companies that need to develop and understand the manufacturing process...

15. ISO 13485:2016 - Design and Development of Medical Devices

4.2

(408)

This is a premium quality course on design and development of medical devices as per ISO 13485:2016 and best industrial practices. ISO 13485:2016 is the international standard for the quality management system of medical devices' manufacturers and suppliers. The standard name is also entitled with an additive expression For Regulatory Purposes. It means the standard is designed in a way to help companies in meeting the regulatory requirements as well. Design and development in a quality management system is the most complex part. Similarly in the medical devices sector, design and development is a complex process which involves various roles and phases. Hence this course is engineered to make the process of design and development of medical devices easier for you to understand. The rising model based on ISO 13485:2016 requirements of design and development is only taught in this course. Rising model is developed by the instructor of this course and is therefore unique way of explaining the ISO 13485 requirements on design and development. What you will learn when you take this online course (Course Objectives): Introduction to ISO 13485:2016FDA Waterfall Model for Design and DevelopmentRising Model for Design and DevelopmentDesign and Development Planning Design and Development ProcedureDesign and Development Inputs Design and Development OutputsDesign and Development ReviewDesign and Development VerificationDesign and Development ValidationDesign and Development TransferDesign and Development ChangesDesign and Development FilesISO 13485 Requirements on Design and DevelopmentNo need to pay thousand dollars for one day awareness course on the design and development of medical devices. This course will suffice your requirement. You will learn the about this new standard ISO 13485:2016 requirements on design and development. NOTICE: Please note that this ISO 13485:2016 standard is ISO copyright protected. A standard copy will NOT be issued with this course. Amazing Offer - Resource Materials: There are two free resources which are exclusively given in this courses. One PDF file for Slides Presentation: All slides of this course is given with first lecture of this course. One PDF file for rising model of design and development: The unique Rising model based on ISO 13485:2016 requirements on design and development is available with the second lecture. Practice Exam: The course also comes with a practice exam to let you analyze yourself about the awareness of design and development taught in this course. Certification: A certificate is also available with this course. Once you complete all lectures and successfully pass the exam, you can have your certificate of successful completion of this course. One Month Money Back Guarantee: Don't forget, this Course have without inquiry, One Month 100% Money Back Guarantee. This means you have unconditionally no risk when registering to this Course. Certificate Issuance Alert from Exoexcellence: Many students have complained that they do not want the new Udemy Certificate (template issued last year). Rather, they wanted the older one. We have communicated their concern to Udemy's management. But please note that is their standard and they are not going to change that for now. So in order to satisfy the need of our students, we have a designed certificate (which is being issued from Exoexcellence Training Resources) which seems satisfactory to our students; raising the concerns. Therefore, now we have a system within the course where you can request a certificate from us after completing the course. Ask Questions & Report Complaints: Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course. Take this course: Follow the "Take This Course Button by clicking at the Top Right Hand Side of the Page. Proceed with the instructions and follow it to register and pay for the course...

16. Internal audit on Medical Device QMS - ISO 13485:2016

4.3

(578)

Internal audit on Medical Device QMS - ISO 13485:2016 is another course created by Stendard Academy to help you gain the skills, and learn how to be an internal auditor for the ISO 13485:2016 standard. In the course, we will cover the general principles of auditing, and walk through all the clauses in this standard, to provide a holistic picture of how audits are and can be performed. This will be done as part of a comprehensive mock audit, performed according to an audit checklist we crafted to thoroughly assess each line in the standard. The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS). It is an essential standard for medical device development companies. Besides being a common regulatory requirement, this standard, when adhered to, provides a Quality Management framework that supports quality products and processes. You may already have a good understanding of the ISO 13485:2016 standard. However, performing an audit according to the standard is a different matter, with the rigour expected. Learning these principles and knowing the documents and records required will be useful should you be in a position that requires you to be prepared for external audits, as similar principles apply. This course has been broken down into: General concepts and principles of auditingEstablishing and preparing for the auditPerforming the audit (How to conduct a mock audit based on compiled checklist?)Reporting the audit resultsPost-audit activities and CAPA planningFor the purpose of this course, we have also compiled a checklist that we would base our mock audit on. This checklist was put together by our team at Stendard in accordance to ISO 13485:2016. The full checklist is available and you will note that we synced it with requirements according to US FDA 21 CFR Part 820 as well. You can download the Audit Checklist. pdf in Section 3.2. and adapt it for your own organisation's usage. Your journey to successfully conducting an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS is only clicks away. We welcome onboard the Stendard Academy, we put quality at the centre of your business and make it easier!...