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

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

Certification Training
 
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Program/Course ID: ELM-328
Enrollment Period: 6 months.
Average 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.
CPD Accredited TrainingCatalog: 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: $199.00 USD  

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

Training Program: EU MDR: EU Medical Device Regulation - Chapters 6 to 10
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon enrollment.

Description:
Biopharma Institute ReviewsThe 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 course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


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 MDR: EU Medical Device Regulation - Chapters 6 to 10 is included in the following professional certification programs:



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 validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: 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 and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


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.
  • Optimized for learning: Courses include voice-overs, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.
  • 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 a PO is required by your company, request an invoice to start the procurement process. we accept all purchase orders.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Tuition reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • 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.
  • 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: 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 requirements have been fulfilled.


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.