This whitepaper outlines in detail the design process required to successfully design a new medical device product, developing it to a point where it can obtain regulatory approval and move into the manufacturing and commercialisation phases.
The whitepaper is based on Arrotek’s well-established Six-Step Design Process. This process has a proven track record of success in advanced catheter design projects and other projects involving the design of minimally invasive medical devices and advanced catheter technologies.
In addition to covering in detail the six essential steps in designing a new medical device product, the whitepaper also covers other essential topic areas. This includes:
- Quality Management System (QMS) – design controls, design reviews, design history file, and risk management
- Design Methodologies and Strategies – concurrent engineering, design for manufacture (DfM), design for assembly (DfA), human factors engineering, and project management
Expert Medical Device Design Team
The Arrotek Six-Step Design Process Whitepaper was put together by our expert team of medical device design engineers and project leads. We used our extensive experience delivering real-world MedTech design projects to produce the most comprehensive resource document available on the process and steps required to design and develop a new medical device.
The whitepaper is completely free to download – simply complete the form on this page and you will be sent a download link.
Get the Six-Step Medical Device Design Process Whitepaper
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