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 5: Classification and Conformity
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 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).
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 5: Classification and Conformity course is included in the following Professional Certification Programs:
Not in Scope
Learning Objectives for this Module
Chapter V: Classification and Conformity
Article 51 - Classification of Devices - Part 1
Article 51 - Classification of Devices - Part 2
Article 52 - Conformity Assessment Procedures - Part 1
Article 52 - Conformity Assessment Procedures - Part 2
Article 53 - Involvement of Notified Bodies in Conformity Assessment Procedures
Class III and Class IIb Devices
Article 54 - Clinical evaluation consultation procedure for certain Class III and Class IIb Devices
Article 55 - Mechanism for scrutiny of conformity assessments of certain Class III and Class IIb Devices
Certificates of Conformity
Article 56 - Certificates of Conformity
Article 57 - Electronic System on Notified Bodies and on Certificates of Conformity
Article 58 - Voluntary change of Notified Body
Article 59 - Derogation from the Conformity Assessment Procedures
Article 60 - Certificate of Free 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.