Course Information
  • Duration
  • 2 Days Course
  • Instructor Led
  • Online Course
  • Course Fee
  • $2200.00
  • Language
  • English
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New EU MDR (European Union Medical Device Regulation) Training Course – Medical Device

$2,200.00

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Description

 

New EU MDR (European Union Medical Device Regulation) Training Course – Medical Device

Note on Private Classes: Our trainers are bilingual, English and Spanish, and are able to teach any course in the language of your choice.

 

COURSE DESCRIPTION:

This course was carefully designed to help you understand and implement the new regulatory requirements of the European Medical Device Regulation (EU MDR) and to obtain and maintain CE marks for your product. The CE mark gives access to a market with 500+ million people.

It was also designed to help you understand and implement best practices for assembling product’s Technical Documentation and organization’s quality management systems when placing Medical Devices (MD) on the European Union market.

The course will also review the requirements of, and relationship between, the legal manufacturer, EU representatives, subcontractors/suppliers, notified bodies, and other economic operators according to their obligations as defined by the EU MDR.

Finally, it will provide you with a step-by-step detail guideline to implement the regulation requirements into your quality management system in a way that you are able to determine its compliance and conformance to applicable related requirements.

 

COURSE OBJECTIVES:

  • Gain the knowledge and skills required to successfully host an audit against the EU MDR regulation
  • Gain the knowledge to perform either an internal MDSAP Mock Audit or an external MDSAP Mock Audit to your supply chain to ensure their compliance and conformance to the EU MDR regulation
  • Understand the regulation’s definitions, concepts, and requirements
  • Obtain the required level of understanding to evolve a strategy for regulatory compliance as stipulated by the EU MDR
  • Understand, implement, and develop strategies for the following aspects of the regulation:
    • Scope and Applicability of MDR
    • EU risk classification criteria for medical devices to determine “Risk Class”
    • General Safety and Performance Requirements (GSPRs) as the basis for CE marking, including the use of  standards and common specifications
    • Identification of economic operators and their related requirements
    • Conformity assessment routes and their application based on risk class
    • Self-certification, CE-certification by Notified bodies, involvement of authorities, scrutiny
    • Declaration of Conformity and CE marking
    • Hosting notified bodies audits
    • Performing audits on your supply chain
    • Review, generation, and/or update of your quality agreements, vendor agreements, vendor controls
    • Implementing the EU MDR requirements into your organization’s quality management system

WHO SHOULD ATTEND?

  • Quality Assurance and Regulatory Affairs Professionals
  • Management Representatives
  • Individuals interested in conducting first-party, second-party, and third-party audits
  • Managers
  • Engineers
  • Consultants
  • Students or industry professionals wanting to learn a marketable skill

DURATION:

2 days

LEARNING STRATEGY:

Our high impact accelerated learning approach utilize leading teaching methods designed to increase knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material.

RESULTS:

On completion, you’ll be awarded a Course Completion Certificate.

An optional test will be provided to those participants who also want to be awarded a Successful Test of Understanding Certificate.

Note: Passing grade to obtain the TOU Certificate is 80%.

PRE-REQUISITES:

Review of the EU MDR before attending the course is highly recommended.

It would be preferred if the participant have experience with, or basic knowledge, of quality systems for the medical device industry, or good understanding of the European Medical Device Legislation.

For Online courses all participants will require an internet connection, speakers, microphone, and a webcam or cam.

ONLINE PLATFORM: 

Online courses will be provided using ZOOM.

ADDITIONAL INFORMATION:

This course will focus on the overall implementation of the MDR, and not on specific devices.

Detailed course notes will be provided either as a hard copy or soft copy depending on the type of course selected (onsite or online).

All requested private courses that are provided onsite or online can be provided in English or Spanish.

RELATED INFORMATION:
All course time shown are US Eastern Standard Time.
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