Course

One Day Workshop Design Controls for Medical Device Development

You have an idea for a new Medical Device. It will improve the Quality of Life of many people. Are you sure people are waiting for your device? This a question you have to ask at the beginning of your development process.  After that and developing your product, you need permission from regulatory bodies to bring is into the market. You have to show that you have followed a controlled development process to ensure a safe medical device.

You have a brilliant idea for a new medical device that will improve the quality of life of many people. You think that many people are waiting for your device. Hence you want to start as quickly as possible, or maybe you are started already with a large dose of enthusiasm.

And of course you are aware that the device should be safe, reliable, easy to handle, easy to maintain, etc. And most important, the main function of the device should give reliable and reproducible results. The device must deliver what the customer or user expects it is delivering.

You start developing, build a prototype, test and redesign. But at some point, inevitable, you will meet the hurdle: the regulations of the FDA and CE. The regulations give you a lot of so called Design Control, which defines what to deliver, but they tell you not how.

This workshop illuminates the road you have to follow from customer needs to a FDA/CE certified medical device. It tells which evidence in the form of data and documents you have to produce during the development process. It will also shortly address the Design for Six Sigma tools and how they can help you improve the design process.

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  • Information
    Course data: 18 december 2018
    Price: € 495.00 ex. vat
    Language
    The program can (partially) be taught in English.
  • Program
    • The benefits of a controlled development process.
    • The elements of a quality management system.
    • A comparison between FDA and CE.
    • The importance of risk management.
    • Failure Mode and Effect Analysis. Classification rules.
    • How does e.g. Six Sigma fit in the development process.

    The design controls:

    • Design and development planning
    • Design input
    • Design output
    • Design review
    • Design verification and validation
    • Design transfer
    • Design changes
    • Design history file