EU Medical Device Regulation (EU MDR) - Chapters 6 to 10
 | Program/Course ID: ELM-328 Enrollment Period: 3 months. Allocated Learning Time: ~60 minutes. Additional Resources: Supplemental materials/activities. Accredited Program: 0.1 CPD Credits. Method of Training: Online / Self-paced eLearning. Accessibility: 24/7 access to all program materials. Catalog: Medical Device Regulatory Affairs.Demonstration: See free trial enrollment courses. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). PRICE: USD $199.00 |
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: EU Medical Device Regulation (EU MDR) - Chapters 6 to 10Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon ordering. Description: Online training with immediate access upon enrollment.  The objective of this course is to provide you with an overview 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.Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements. Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn. |
Outline:Introduction Overview Introduction Learning Objectives for this Overview The Background of the EU MDR 2017/745 1901 - Jim the Horse Tetanus Scandal 1959 - Primodos 1996 - ISO 13485 Medical Devices - Quality Management Systems 2018 - Vaginal Mesh Implants A Regulatory Evolution Introduction to EU MDR The Regulation Chapters and Articles Annexes The EU MDR Timeline What this means MDD vs MDR Chapters VI to X Chapter VI Clinical Evaluation Conduct of a Clinical Investigation Informed Consent Coordinated Assessment Procedure for Clinical Investigations Implementing Acts Chapter VII Post-Market Surveillance System of the Manufacturer PMS Report Reporting of Serious Incidents and Field Safety Corrective Trend Reporting Chapter VIII Competent Authorities Medical Device Coordination Group (MDCG) Chapter IX Confidentiality Data Protection Penalties Chapter X Committee Procedure Exercise of the Delegation Industry Pain Points Product Rationalization Notified Body Capacity Economic Operators - Supply Chain Impact Restricted Substances Claims Management Post Market Surveillance & Vigilance Post Market Surveillance Vigilance Clinical Evidence Labelling, IFUs, Patient cards and Layman's language IT Systems Conclusion Final Assessment Certification | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of The European Union Medical Device Regulation (EU MDR). | |
EU Medical Device Regulation (EU MDR) - Chapters 6 to 10 is Included in the Following Professional Certification Program(s):
 | Training Program For Professionals: EU Medical Device Regulation (EU MDR) for Professionals Course ID: EUMDR Price: $1295.00 (USD) | Learn more |
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.
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-scale (1-100 students) and large-scale (100+ students) training requests.
Online Training: The Benefits of Remote Learning & eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
- Tuition reimbursement: Some employers may reimburse for training expenses; check on 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.
- Purchase orders (POs) accepted: If 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.
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- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.
