このトレーニングに期待すること
Integrating a robust quality management system (QMS) for your point-of-care 3D printing facility is crucial to ensure that the devices produced are safe, effective, and compliant with the increasingly demanding regulations.
In this training, you will learn how to build or enhance a process-based strategy at your point-of-care 3D lab by adding a quality assurance framework, increasing the efficiency of your clinical service.
This modular course includes video classes and templates that can help and assist you in any QMS implementation, including an MDR-specific module. You can also attend a Q&A session with one of our experts in QMS, which is available upon request.
The content is based on our 30+ years of experience as a medical device manufacturer, and it will provide you guidance in building a QMS that matches the additive manufacturing (AM) applications within your hospital’s existing framework.
実用情報
対象
3D point-of-care facility managers
レベル
All
フォーマット
Online: video classes and live Q&A session available upon request
期間
5 to 7 hours commitment, depending on your learning pace, with three-month access to the content.
認証
Certificate of attendance
前提条件
Only available for Materialise Medical software customers
評価
100% of participants recommend this training
価格
$1,500 USD
What you will learn
- How to build a QMS that complements your hospital’s existing QMS framework
- How to build a QMS that matches the clinical applications of your 3D lab
- How to integrate a QMS that focuses on existing and future legislation and regulations, such as article 5(5) of the new MDR*
Training from an industry leader
30+ years of excellence
Benefit from our decades of experience as a medical 3D printing device manufacturer, which includes meeting all necessary requirements while operating within a regulated QMS.
Future-proof your workflow
Integrate a QMS that focuses on EU legislation requirements, including article 5(5) of MDR.
Taught by AM experts
Gain insights from expert trainers with tons of practical knowledge, proven templates, and live Q&A sessions.
Lessons included in this training
An overview of quality management systems
Gain an overview of the different components that make up a QMS and learn how to incorporate them into your institution.
Production quality assurance
Discover how you can ensure repeatability and decrease the risk of production errors through a QMS.
Design quality assurance
Find out how implementing a QMS can improve the quality and consistency of your device design.
European Union Medical Device Regulation (EU MDR)
Focus on the elements of MDR that directly impact 3D printing at the point of care and the documentation required to continue your operations.
Technical documentation
Learn how to accurately document every stage of your development process, capturing device history and ensuring traceability.
Frequently asked questions
*The content in this masterclass is intended to guide and instruct on existing regulations that may be relevant to point-of-care 3D printing. Acceptance or clearance of actual execution and audit of created processes and documentation is not guaranteed as part of this training. One module contains specific MDR information and is designed for an EU audience.
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