EU Medical Device Regulation (EU MDR) for Professionals
 | Enrollment Period: 12 months. Average Learning Time: ~20 - 29 hours. Additional Resources: Supplemental materials/activities. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials.Courses: Program includes 13 individual courses (see courses). Outline/Syllabus: See individual course pages for outlines. Digital Badge: Issued upon completion. Catalog: Medical Device Regulatory Affairs. Demonstration: Three (3) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). Price: $1295.00 USD |
Download Program DetailsDocument your dedication to compliance, safety, and job performance by earning a professional certification. Training Provided By: Biopharma InstituteWebsite: https://www.biopharmainstitute.com Outline/Syllabus: See individual course pages for outline. Description: This EU Medical Device Regulation (EU MDR) for Professionals program includes 13 separate courses. An introductory course is used to explain how, why, and when the new regulations have come into force; what they consist of; and some of the new and strengthened features. We will look at some of the historical events that have occurred over a period of decades, their consequences, and students will be able to understand the triggers for changes in legislation, and what brought these changes about. This module includes a high-level overview of the contents of EU MDR 2017/745, some of the new features, the timelines for compliance, and will examine how the new MDRs compare to MDD. In the next course, we will cover Chapter 1 - the Subject Matter and Scope, which sets out what this regulation applies to as well as what this regulation does not apply to. We shall also examine where a decision is required to determine which set of regulations (other than EU MDR 2017/745) a product is governed by. EU MDR 2017/745 - Chapter II: Making available on the market and putting into service of devices, we discuss Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement. This Chapter continues to expand on some of the definitions given in Chapter I, and introduces activities to be undertaken by Economic Operators before a product is placed on the market, when it is placed on the market, and after it is placed on the market in the European Union. EU MDR 2017/745 - Chapter III: Identification and traceability of devices, Registration of Devices and of Economic Operators, Summary of Safety and Clinical Performance, European Database on Medical Devices. There are 10 articles in this chapter. Articles 25 through 34 are discussed. Articles 25, 26, 28 and 34 are comparatively short, so naturally we shall spend the bulk of the time in this module examining the other six articles. EU MDR 2017/745 - Chapter IV: Notified Bodies. This training module entails a full review of the role of a Notified Body and how it interfaces with other regulatory bodies including Member States Authorities Responsible for Notified Bodies, the EU Commission and the Medical Device Coordination Group (MDCG). There are sixteen Articles in this chapter. Articles 35 through 50 are discussed. Articles 37, 38, 40, 41, 43, 49 and 50 are comparatively short so naturally we shall spend the bulk of the time in this module examining the other nine articles. EU MDR 2017/745 - Chapter V: Classification and Conformity Assessment. There are ten articles in this Chapter V, articles 51 through 60. In this course we will look more closely at the specific details in the regulation surrounding some of the key topics discussed. There are seven distinct areas in this chapter from Classification of Devices (Art 51) to Certificate of Sale (Art. 60). EU MDR 2017/745 - Chapter VI: Clinical Evaluation and Clinical Investigations. This is a significant and exciting chapter introducing a life-cycle approach to ongoing CE Marking compliance. It is a process, not a project. One output of the clinical evaluation process is demonstrating clinical performance of the medical device, i.e. demonstrating that the device performs as intended and has benefit to patients. Clinical data in support of performance can come from many sources including: clinical literature, trials, usability, post-market clinical follow-up (PMCF), the state-of-the-art, and/or from 'equivalent' devices. EU-MDR - Chapter VII - Post Market Surveillance, Vigilance and Market Surveillance. In this course, we will look more closely at the specific details in the regulation surrounding some of the key topics discussed under this chapter of the regulation. There are eighteen articles in this chapter: articles 83 through to 100 inclusive. Articles 84, 85, 88 and 90 are comparatively short so naturally we shall spend the bulk of the time in this module examining the other fourteen articles. EU-MDR - Chapter VIII - Cooperation Between Member States, Medical Device Coordination Group, Expert Laboratories, Expert Panels and Device Registers. In this course, we will look more closely at the specific details in the regulation surrounding some of the key topics discussed under this chapter of the regulation. There are eight articles in this chapter: articles 101 through to 108 inclusive. Articles 101, 102, 104, 107 and 108 are comparatively short so naturally we shall spend the bulk of the time in this module examining the other three articles. EU-MDR - Chapter IX - Confidentiality, Data Protection, Funding and Penalties. This course will examine Chapter 9 of the EU Medical Device Regulation (EU MDR), describing confidentiality, data protection, funding, and penalties. EU-MDR - Chapter X - Final Provisions. There are ten articles in this chapter: Articles 114 through to 123 inclusive. In spite of the number of articles, this is a relatively short module considering the content, with most of the articles being quite brief. This training module entails a review of the requirements that have to be in place prior to fully implementing EU MDR 2017/745. There are four sections to this chapter, Committee Procedures (Article 114), Delegation (Articles 115 and 116), Amendments (Articles 117 to 119) and Stages on Introduction (Articles 120 to 123). EU Medical Device Regulation (EU MDR) for Professionals includes these 13 individual courses:
Additional Information:Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements. Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity or recertification period for employee compliance training would be determined by those responsible for managing quality within the company. Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into any program or course. Students may attempt the final assessments any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format. Additionally, once the student has completed the professional certification program, a digital badge is issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display accomplishments. Benefits of Being Certified from Biopharma Institute: Throughout the online training courses students will be engaging in active learning using interactive eLearning modules developed to promote the retaining of key knowledge. Furthermore, students will be provided with access to references, the regulatory guidelines, case studies, and other important information necessary to gain a professional understanding for the discipline. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with attaining their training requirements. Our courses are developed by subject matter experts (SMEs) in the topic of study and have all been validated and/or accredited by a neutral 3rd party. Biopharma Institute certifications are recognized by regulators and companies in a wide range of industries around the world. Biopharma Institute has training solutions which are customizable to any organization's training needs. We aim to provide only the highest quality of training, which is current, engaging, effective, and easy to navigate. Today, Biopharma Institute has over 200+ courses in its catalog. These courses train on clinical trials, drug manufacturing, regulatory affairs, validation systems, drug safety, pharmacovigilance, good laboratory practice, and data integrity; all within the medical device, clinical research, and pharmaceutical industries. Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We cater to both small and large-scale training requests. |
Benefits of Training with Biopharma Institute
| Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
| Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
| Open enrollment: | No prior course prerequisites or work experience required. |
| Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
| Current and validated: | Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited. |
| Optimized for learning: | Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter. |
| Secure and safe access: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Certificate of completion is instantly available once requirements have been fulfilled. |
| Verification of training: | Certificates verifiable online with digital badges issued for all professional certification programs. |
| Training manager access: | A proprietary portal offers access to download enrollment reports, training records, account balance, and more. |
| SCORM-compliant courses: | Courses can be delivered directly to most corporate Learning Management Systems (LMS). |
| Purchase orders (POs): | POs are accepted from all companies. Request an invoice when starting the procurement process. |
| Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company's policy. |
| Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
| Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
