Method of Training: Online / Self-paced eLearning.Credits: 0.1 CPD Credits.
Duration: ~45 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) - Chapter 4: Notified Bodies
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. 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.
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) - Chapter 4: Notified Bodies course is included in the following Professional Certification Programs:
Chapter IV: Notified Bodies
Article 35 - Authorities Responsible for Notified Bodies
Article 36 - Requirements Relating to Notified Bodies
Article 37 - Subsidiaries and Subcontracting
Article 38 - Application by Conformity Assessment Bodies for Designation
Article 39 - Assessment of Application
Article 40 - Nomination of Experts for Joint Assessment of Applications for Notification
Article 41 - Language Requirements
Article 42 - Designation of Notification Procedure - Part 1
Article 42 - Designation of Notification Procedure - Part 2
Article 43 - Identification Number and List of Notified Bodies
Article 44 - Monitoring and Re-Assessment of Notified Bodies - Part 1
Article 44 - Monitoring and Re-Assessment of Notified Bodies - Part 2
Article 45 - Review of Notified Body Assessment of Technical Documentation and Clinical Documentation
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.