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Home » EU Medical Device Regulation (EU MDR) for Professionals

EU Medical Device Regulation (EU MDR) for Professionals

Certification Training
 
Rated 4.15/5
20 reviews
Program/Course ID: EUMDR
Enrollment Period: 12 months (1 year).
Average Learning Time: ~14 - 20 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: Program includes 9 individual courses (see courses).
Outline/Syllabus: See individual course pages for outline.
Digital Badge: Issued upon completion.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $1295.00 USD  

Document your dedication to compliance, safety, and job performance by earning a professional certification.

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Outline/Syllabus: See individual course pages for outline.
Description:

This program includes 9 separate courses or training modules. The learning objectives of these modules are described here. 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 and their consequences, and we will be able to see the triggers for changes in legislation and understand 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 we'll look at how the new MDRs compare to MDD.

In the next course, we will cover Article 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.

Welcome to EU MDR 2017/745 - Module 2 - Chapter II - Making available on the market and putting into service of devices, Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement. This Chapter expands 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.

Welcome to EU MDR 2017/745 - Module 3 -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 to 34 inclusive. 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.

Welcome to Module 4 - 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 to 50 inclusive. 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.

Welcome to EU MDR 2017/745 - Module 5 - Chapter V - Classification and Conformity Assessment. There are ten articles in this Chapter V (articles 51 through to 60 inclusive) and in this module we'll 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).

The objective for this course is to provide you with a review of the EU MDR 2017/745. This overview will guide you through the following the background of the EU MDR, why it was introduced, the EU MDR structure and timeline, the main differences between MDD and MDR, an overview of each chapter and some of the key challenges facing organizations due to its introduction. It is designed to provide the student with a high-level comprehension of the regulation and what it means for organizations in today's world of medical device manufacture.

Chapter VI - Clinical Evaluation and Clinical Investigations 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 Medical Device Regulation (EU MDR) for Professionals includes these 9 individual courses:

(Click on course links below to see outline/syllabus)



Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation - Introduction

Course ID: ELM-316
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation - Chapter 1: Scope and Definitions

Course ID: ELM-317
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation - Chapter 2: Making Available on the Market

Course ID: ELM-318
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation - Chapter 3: Identification, Traceability and Registration of Devices

Course ID: ELM-319
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation - Chapter 4: Notified Bodies

Course ID: ELM-320
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation - Chapter 5: Classification and Conformity

Course ID: ELM-321
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

EU-MDR - Chapter VI - Clinical Evaluation and Clinical Investigations

Course ID: ELM-322
Duration: 45 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation - Chapters 1 to 5

Course ID: ELM-327
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation - Chapters 6 to 10

Course ID: ELM-328
Duration: 60 minutes (0.1 CPD Credits)
Price: Included | Learn more

Additional Information:

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessments 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 period for employee compliance training would be determined by those responsible for managing quality assurance.

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 the accomplishment.

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 catering to both small and large-scale training requests.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Purchase orders (POs): If issuing a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.