0012-EUMDR-2017-745-implementation-and-advanced-requirements-training

EU MDR- Implementation and Advanced Requirements for EU MDR 2017/745

Face-to-face Training02 DaysIntermediateVirtual Classroom
  • Practical knowledge of implementing the latest Medical Device Regulation EU 2017/45
  • Key takeaways while transitioning from Medical Device Directive (MDD) to Medical Device Regulation (MDR)
  • Develop new skills to work efficiently in the regulatory departments of an organization and help comply with the ever-changing regulatory advisories
  • Competitive knowledge to address technical documentation requirements related to MDR
  • Limited Premium Access to Technical Documentation – MDR e-Learning Module


**If you are unable play the video below, this could be because of your company IT policy may have restricted access to YouTube.

For medical device manufacturers, implementation of European Medical Device Regulations is one of the primary requirements while placing their products in the European market. Along with this, medical device manufacturers need to ensure compliance towards the EU MDR for getting the Conformité Européene (CE) markings on the products. Through our training program, we help you understand the process of CE markings. The European Council Directives 90/385/EEC and 93/42/EEC have been revised to Regulation (EU) 2017/745. The two-day training helps you gain knowledge about and transitioning from the MDD to MDR. The Regulation (EU) 2017/745 covers medical devices and active implantable medical devices. This regulatory framework defines the expectations of the European Commission and medical device manufacturers, notified bodies, and member state competent authorities.

  • Introduction to the European Union Medical Device Regulation
  • Implementation timelines for manufacturers
  • Regulatory expectations against various annexes
  • General Overview of training:
    • Question and answer session
    • General safety and performance requirements
    • Technical documentation
    • What is meant by the EU Declaration of Conformity?
    • What information will be submitted upon device registration, including the UDI system?
    • Requirements to be met by Notified Bodies
    • Classification rules for medical devices
    • Conformity assessment based on quality management system and assessment of the technical documentation
    • Conformity assessment based on type examination
    • Conformity assessment based on product conformity verification XII Certificates issued by a notified body
    • Procedure for custom-made devices
    • Learnings of clinical evaluation and post-market clinical follow-up
    • Carrying out clinical investigations
    • List of groups of products without an intended medical purpose
  • Technical documentation on post-market surveillance
  • Examination – MCQ-based.

Research and Administration

  • Product developers
  • Regulatory managers
  • Quality assurance
  • R&D professionals

Engineering

  • Engineers

Management

  • Operational managers
  • Manufacturing managers
  • Other service providers associated with the medical devices industry

Candidates are recommended to have prior experience in relevant fields applicable as per the training program.

Bringing out the best in your people starts with having the right training partner. Our trainers are selected through a rigorous screening before earning a place on board. Our experts are certified and extremely competent, with ample experience across various industry segments. They have exposure to advisory roles with various relevant industries. They have current, real-life corporate business experience and training skills.

Our EU medical device regulation training partners are experts in their industry, with hands-on experience in training and communication, in-depth knowledge of the standards and regulations that affect your business and providing you with the best learning experience. Also, they have hands-on experience in applying these standards across various industry domains.

  • Understand additional requirements in MDR.
  • Gain functional knowledge of the current regulation: EU MDR 2017/745 and ISO 13485:2016
  • Basic understanding of technology and certification requirements
  • Learn about the transition from MDD to MDR
  • Develop new skills to work in various regulatory teams, such as technical documentation, clinical evaluation reporting, and post-market surveillance
  • Learn how to comply with EU MDR 2017/745
  • Understand the CE Certification process and timelines for different medical device manufacturers

The Implementation and Advanced Requirements under EU MDR 2017/745 can be obtained by enrolling and attending our instructor-led training program. Post-completion of the EU MDR training course, participants are required to attend an examination containing multiple-choice questions to obtain the certificate. Participants scoring above the passing criteria would be awarded the successful completion certificate by TÜV SÜD South Asia.

Examination Pattern

  • Exam Type: Multiple choice
  • Exam Questions: 50
  • Exam Time: 60 minutes
  • Required number of points: 30 points
  • Maximum number of points: 50
  • Aids: Open Book
  • Passing Criteria: 60%

1. Are there any prerequisites to apply for the course?
Candidates are recommended to have prior experience in relevant fields applicable as per the training program.

2. How does the EU MDR Training help me?
The two-day - EU MDR training aims to help candidates in the quality and regulatory field gain in-depth knowledge of the requirements, including transitioning from MDD to MDR and implementation requirements of MDR. Participants engage in various exercises and assignments throughout the two days of this interactive training. This helps participants gain practical knowledge and apply this to their day-to-day work.

3. Can I get the course content?
We share the training content with all participants before the start of the training.

4. Can I get the recording of the sessions?
All training sessions are conducted live and are interactive. Recording of the training sessions is not permitted.

5. When do the final exams take place?
The final examination access is sent to your registered email ID on the last day of the training program. The access remains valid for 72 hours after the training is completed. Participants must submit the online examination within the stipulated time. This will be considered the first attempt if the participant fails to submit the examination within the stipulated time. For Lead Auditor Courses: The final examination is conducted on the final day of the training program.

6. How long does it take to get the e-certificate?
Once you have submitted the final examination, it is sent for evaluation. General evaluation requires three weeks to be completed. The result, followed by the e-certificate, is released after evaluation is completed.

7. How can I get the physical copy of the e-certificate?
We provide a physical copy of the e-certificate at an additional charge. You may email us requesting a physical copy after receiving the e-certificate.

8. Can I take the examination without attending the course?
As per the guidelines, participants are required to attend the complete training to be eligible for the final examination.

9. What if I fail the examination?
Participants are eligible to take a second attempt if required. The second attempt at the final examination is provided at an additional charge. You may write us an Email in case you are required to appear for a second attempt for the final examination.

10. What are the program timings?
The standard program timings are from 9:30 am to 5:30 pm IST each day.

11. How do I register?
You can register by paying the training fees on the online portal. Following this, you will receive a confirmation about your enrollment in the preferred batch.

12. Is there any refund policy for the paid fees?
Please refer to Cancellation and Refund Policy page.

  • Stryker
  • Meril Healthcare Pvt. Ltd.
  • Boston Scientific
  • Thermo Fisher Scientific
  • Draeger India Pvt. Ltd.
  • HCL Technologies Ltd.
  • Medtronic India Pvt. Ltd.
  • Siemens Healthineers
  • Tata Consultancy Services
  • Becton, Dickinson & Company
Net Price (excl. GST)
₹ 15,000.00
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