Method of Training: Online / Self-paced eLearning.Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
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 1 to 5
Training Provided By: Biopharma Institute
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 with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
EU Medical Device Regulation (EU MDR) - Chapters 1 to 5 course is included in the following Professional Certification Programs:
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
Chapters and Articles
The EU MDR Timeline
What this means
MDD vs MDR
Chapters I to V
Out of Scope
Placing on the market and putting into service
General obligations of Manufacturers
General obligations of Importers
General obligations of Distributors
Person Responsible for Regulatory Compliance (PRRC)
Medical Devices Nomenclature
Registration of Devices
Unique Device Identification System
Authorities Responsible for Notified Bodies
Requirements Relating to Notified Bodies
Assessment of Application
Classification of Devices
Assessment of Conformity
Certificate of Sale
This training program has been developed to train employees with Intermediate Knowledge of The European Union Medical Device Regulation (EU MDR).
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.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- 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.