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Home » EU Medical Device Regulation (EU MDR) - Chapter 2: Making Available on the Market

EU Medical Device Regulation (EU MDR) - Chapter 2: Making Available on the Market

Certification TrainingProgram/Course ID: ELM-318
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.
CPD Accredited TrainingCatalog: 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) - Chapter 2: Making Available on the Market
Training 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. Biopharma Institute ReviewsWelcome to EU MDR 2017/745 - Module 2 - Chapter II - Making available on the market and putting into service of devices, Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement. This Chapter expands on some of the definitions given in Chapter I and introduces activities to be undertaken by Economic Operators before a product is placed on the market, when it is placed on the market and after it is placed on the market in the European Union.

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
Previous Module
Module Introduction
Learning Objectives for this Module

Articles 5 to 9
Article 5 - Placing on the Market and Putting into Service
Article 6 - Distance Sales
Article 7 - Claims
Article 8 - Use of Harmonized Standards
Article 9 - Common Specifications

Articles 10 to 16
Article 10 - General Obligations of Manufacturers - Part 1
Article 10 - General Obligations of Manufacturers - Part 2
Article 11 - Authorized Representative - Part 1
Article 11 - Authorized Representative - Part 2
Article 12 - Change of Authorized Representative
Article 13 - General obligations of Importers - Part 1
Article 13 - General obligations of Importers - Part 2
Article 14 - General obligations of Distributors
Article 15 - Person Responsible for Regulatory Compliance - Part 1
Article 15 - Person Responsible for Regulatory Compliance - Part 2
Article 16 - Cases in which Obligations of Manufacturers Apply to Importers, Distributors or Other Persons

Articles 18 to 20
Article 18 - Implant Card and Information to be Supplied to the Patient with an Implanted Device
Article 19 - EU Declaration of Conformity
Article 20 - CE Marking of Conformity

Articles 17 to 23
Article 17 - Single-Use Devices and their Reprocessing
Article 21 - Devices for Special Purposes
Article 22 - Systems and Procedure Packs - Part 1
Article 22 - Systems and Procedure Packs - Part 2
Sterilization of Systems and Procedure Packs
Article 23 - Parts and Components

Article 24 - Free Movement
Article 24 - Free Movement

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) - Chapter 2: Making Available on the Market 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.
  • 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.


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