Implementation of Medical Device Regulation for CE Marking Training Course

等級標準建置期間 3 days

可報名: 線上直播 NT$ 17999 Book your place

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market. The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.

This course aims to offer guidance on implementation of the requirements stipulated in the MDR. It focusses on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your business and your documentation. Moreover, you should gain confidence and expertise to evaluate and implement more specific requirements on your own.

How will I benefit?

This course will help you:

Implement the requirements of the European Medical Devices Regulation
Guide and support other people and partner organizations affected by MDR
Set up and update required documentation
Take the necessary steps for your organization to meet the MDR requirement
Maintain compliance to MDR and other/future documents related to Medical Device legislation
Systematically explore and implement more detailed and updated provisions (e.g. common specifications (CS), acts, standards)

You must have a good understanding of the requirements in the MDR, which is conveyed by our one-day Requirements training course or our MDD to MDR transition course. You should also have either experience with, or basic knowledge, of quality management systems for the medical device industry, or good understanding of European Medical Device.

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