Guidelines to use this board with the fx3 superspeed explorer kit can be found in the following book. Deploying the sample to deploy this sample in your environment. The design history file, or dhf, is part of regulation introduced in 1990 when the u. Pdf file or convert a pdf file to docx, jpg, or other file format. Formswift and easepdf are two examples of online pdf to word converters that can save the. Until that time, these documents are provided for the use of.
This guide takes a practical approach to designing and implementing superspeed usb peripherals. This reference design can also be used as a hardware reference design for any implementation using the hd3ss3220 with a usbc connector. Technical documentation has to be developed during the design and development process of a device and maintained throughout its entire life cycle. Test descriptions provide a high level overview of the tests that are performed to check the. New superspeed book now available usb design by example.
He has helped people design, debug, and get into production, an enormous span of products. As an example, have a project starting date where all stakeholders can truly participate on your specified time. The medical device milestone map clinical validation is obtained after a device has been used successfully in a pilot trial in which all clinical endpoints were achieved. The total finished design output consists of the device, its packaging and labeling, and. John has been involved in usb since its inception and wrote his first usb design by example book in 1999. These documents were created by the global harmonization task force ghtf.
Ifd in output designer and recompile the template for the appropriate presentment target. When still being a youngster, mom used to order us to constantly check out, so did the educator. Refer to the superspeed device design by example book, by john hyde. Can anyone provide a template for design and development plan for a medical device. You also need to be particular with the dates of each project phases and ensure that they are laid out in an efficient manner.
Device master record dmr means a compilation of records containing the procedures and specifications for a finished device. Adobe pdfmaker with microsoft word as an example, this guide provides. Download superspeed device design by example free pdf, download superspeed device. The finished design output is the basis for the device master record. Download and install the best free apps for pdf software on windows, mac, ios, and android from cnet download. Audible warning devices such as bells, horns, strobes, speakers and displays may not alert people if these devices are located on the other side of closed or partly open doors or are located on another floor of a building. As illustrated in figure 1, this process can be represented using the vmodel, as it delivers documents and records, which form the design history file dhf. Usb typec plug to usb typea receptacle superspeed mux.
White paper device master records and medical device files. A design history file is a compilation of documentation that describes the design history of a finished medical device. We will certainly commonly discover out this sentence everywhere. In plain language, it is a file that will look the same on the screen and in print, regardless of what kind of computer or printer someone is using and regardless of what software package was originally used to create it. Download or read online button to get superspeed device design by example book now. Superspeed device design by example, by john hyde, is the latest in a series of howto usb books. This tue to get superspeed device design by example. The device is designed to protect highspeed interfaces such as superspeed and hispeed usb combination, sdmemory card 3. Where can i get information about superspeed device design by example, by john hyde.
Usb implementers forum interoperability test procedures. You may also see project worksheet examples in pdf. About portable document format pdf files what is a pdf file. The device is designed to protect highspeed interfaces such as superspeed usb 3. For example, if you save a pdf on a mac, it will appear the same. Example from low energy printing project p09505 project background. Due to its large file size, this book may take longer to download. It is meant to be used for the examples mentioned in the book superspeed device design by example, by john hyde. Comments off on superspeed device design by example the. Congress passed the safe medical devices act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. A portable document format pdf file is a selfcontained crossplatform document. Design by example pdf, read online superspeed device design 11 nov 2018. A trusted document is a document that you or an author you trust has approved.
Qa project plans are one component of epas quality system. I am warmed to see that a usb connection is now standard on almost every piece of electronic equipment. Sign up with free trial and start converting scanned paper forms or digital forms to fillable pdf documents. Usb hardware design guide an0046 application note this application note gives recommendations on hardware design for implementing usb host and device applications using usb capable efm32 microcontrollers. Then you can start reading kindle books on your smartphone, tablet, or computer no kindle device required. The book describes stepbystep what you need to do to be successful with a superspeed device design after reading the book you will discover that its not that difficult after all. I wrote my first usb book, usb design by example, while working at intel corporation. Download superspeed device design by example pdf ebook. Enter your mobile number or email address below and well send you a link to download the free kindle app. This book is really great, but all visual studio projects were a little outofdate, so i retargetrecompile with visual studio 2017 community on windows 10 with some fixes to get rid of compile errors. This document serves as the consultation paper that integrates the minds of the client and the designer or creative team to come up with an agreed initial plan to achieve the desired outcome. Fda regulation of medical devices congressional research service summary prior to and since the passage of the medical device amendments of 1976, congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from. Download pdf superspeed device design, by example, by john hyde.
Playing video, audio, and multimedia formats in pdfs. By setting your permissions to play multimedia only in trusted documents, you can prevent programs, macros, and viruses from potentially damaging. Review, document, approve, and update as developments and changes evolve. Generally usb devices must always operate at their maximum possible speed for example a superspeed device attached to a hi speed port must operate at hi speed. The device includes six highlevel esd protection diode structures for ultra highspeed signal lines. Examples logowhenever there is a design project that is required to be conceptualized, planned, or presented, a design brief is always deemed necessary. This design example shows the hardware abstraction layer hal software device driver development process for the uart. Superspeed device design by example 1, john hyde, ebook. Superspeed device design by example and millions of other books are available for amazon kindle. Enhancements such as superspeed, new class drivers, wireless, otg and embedded hosts continue to expand usbs applications range. This document provides the compliance criteria and test descriptions for superspeed usb devices, hubs and host controllers that conform to the universal serial bus 3. A pdf file is a portable document format file, developed by adobe systems. The book is based on the cypress fx3 superspeed device and the firmware. The sample size of a pilot trial is usually equal to the minimal number of patients necessary for the results to hold statistical significance.
This could be a howto book which explains, with palmson examples, how one can design and implement a superspeed usb peripheral which will interface to your hardware using a 32bit 100mhz bus with commonplace or custommade protocols. Ciw web and mobile design series student guide ccl02cdhtcsck1405 version 1. Design control guidance for medical device manufacturers fda. As a result this secondary document exists to provide an interoperability test scenario for such a device and if applicable any associated software. If a project came along for a device which required service, the project plan would note what needed to be added to the dhf for the project. Technical documentation and medical device regulation. Final epa qag5s i december 2002 foreword this document, guidance for choosing a sampling design for environmental data collection epa qag5s, will provide assistance in developing an effective qa project plan as described in guidance for qa project plans epa qag5 epa 1998b. Assists manufacturers in understanding the intent of the regulation. Design controls are based upon quality assurance and engineering principles. Thus, all the marketing authorization holders mahs shall have this license.
Modify the sendfile to look for the device with the vidpid of 0x04b40x00f0 which is the vidpid present in the. Superspeed device design, by example, by john hyde. Cyclone iv and cyclone v powerplay early power estimator ver 14. This guide is optimized to work with the fx3 superspeed explorer kit.
Guidance on choosing a sampling design for environmental. Achieving lowest system power with lowpower 28nm fpgas ver 1. The project plan could also document which deliverables from this project would use prior work, for example when the project is an extension of an existing design. Reference design files can be provided upon request to aid pcb design. In the case of medical devices, design, main assembling, sterilization and domestic japan distribution site shall be registered. Any warning device may fail to alert people with a disability or those who have recently consumed drugs, alcohol, or.
For more details refer fda guidance document design control guidance for medical device manufacturers section b design and development planning regards s. The tida00891 is designed to evaluate hd3ss3220 devices for ufp implementations. Design failure modes and effects analysis a structured approach that ensures potential product failure modes and their associated causes have been considered and addressed in the product design what can go wrong. Learn how to create a fillable pdf form with adobe acrobat dc. Superspeed device design by example 1, hyde, john, ebook. Superspeed device design by example the disrespectpolyzoic. When this check box is selected, and youre signed in to acrobat reader or acrobat, the added signature is saved securely in adobe document cloud for. Pdf is a file format designed to present documents consistently across. The external hard drive features the nero backlt up and burn.
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