Requirements of the Medical Device Regulation (EU MDR) Training Course
There's no denying that the Medical Device Regulation (MDR) Training Course's primary objective is to study the concepts, essential requirements, and the overall process for CE marking. Furthermore, the CE mark provides access to a market with 500+ million people.
An Understanding of the Key Requirements:
• The course will provide you essential knowledge for comprehending the regulatory affairs of medical devices in the EU.
• The course will provide you the ability to realize the subcontractor's demands, OEM, authorized representative, supplier, importer, distributor, encouraging better relationships between them and the legal manufacturer.
• The course will provide a valuable medium to learn about the implementation of CE marking projects.
Course Description
To put it simply, the Medical Devices Regulation is the directive focusing on the various demands that manufacturers face to meet medical devices on the market in the European Union.
The regulation course will impact all medical device importers, distributors, manufacturers, and EU Representatives. Furthermore, suppliers will also be affected, and manufacturers of some devices without a medical purpose.
It's essential to mention that the MDR focuses on device safety and performance, emphasizing pre-market requirements, quality management aspects, conformity assessment, Post Market Surveillance (PMS), traceability, and transparency; their conditions will also influence audits and governmental control.
Additionally, the course covers the critical concepts of the European Medical Devices Regulation. Every medical device must go through a Conformity Assessment Procedure- as per the MDR requirements suggested by the European Union market. This will allow you to get a comprehensive understanding of the requirements stipulated within MDR.
Who Should Attend?
Here's a detailed breakdown of the suitable person who would be appropriate for the course.
• Individuals are starting in the Regulatory Affairs (RA), RA professionals unaware of the European MDR, and people who are increasing their responsibility in this area.
• People involved with Regulatory Affairs departments, e.g., project member in QM/QA, R&D or top management, manager, supply chain, design, manufacturing, customer service, and sales.
• People engaged with organizations that collaborate with Medical Device manufacturers, e.g., supplier, subcontractor, OEM, authorized representative, audited, importer, distributor, etc.
Prerequisites: There's no denying that there are no formal prerequisites for the EU MDR course. However, people are likely to gain a fundamental knowledge of medical device use, manufacture or design, and a general understanding of quality management.
What Will I Learn?
Here's a detailed breakdown of the things you can learn to post the conclusion of the course.
• You will be able to define the vocabulary used within MDR
• You will be able to communicate the essential concepts and demands within the Regulation
• You will be able to reference the relevant aspects to analyze if and how MDR can affect and to what extent.
• You will be able to elaborate on the administration and structure of the Regulation
• You will be able to define the pressing impacts on the QMS (quality management system) relating to EU MDR
• You will be able to identify partners of manufacturers influenced by the Regulation
• You will be able to explain the critical steps of a conformity assessment
• You will be able to identify the necessities for post-market updates and surveillance
How Will I Benefit?
Here's a detailed breakdown of the several benefits of the course.
• You will be able to process the essential concepts and requirements of the European Medical Devices Regulation
• You will be able to communicate the effects of the critical requirements introduced by the MDR
What's Included?
Here's a detailed breakdown of all that you can find in the course. There's no denying that the system will emphasize the overall MDR requirements and not on specific devices or implementation issues.
• Once you complete the training, you will receive an internationally acknowledged BSI Training Academy certificate.
It's essential to mention that the Medical Device Regulation (MDR) is an exclusive set of regulations that oversee medical devices' development and distribution. Furthermore, it successfully manages compliance with the Regulation for medical device companies.
There's no denying that implementing European Medical Device Regulations is a fundamental necessity while complying with the regulatory requirements. This is all while placing CE marking on the products and placing the products in European Market for the Medical Device manufacturers.
