Safety and Regulatory Aspects of Systems for Disease Pre-Screening

Safety and Regulatory Aspects of Systems for Disease Pre-Screening

DOI: 10.4018/978-1-5225-7131-5.ch011
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Pre-screening solutions for disease prediction fall under medical device regulations because of the intended purpose of diagnosis. The chapter begins with an overview of the medical device regulations focusing on the two major regulations. The definition of a medical device to the guideline of how a medical device is classified is then discussed. The later part of the chapter covers the design control process with stages of user needs translating to requirements, the design process with the design outputs, design verification conforming that the design is right, followed by design validation that proves that a right medical device is made. The risk management, usability engineering, and security and privacy risk management are part of the product realization process. Having a clear regulatory strategy and plan beginning with the list of target countries and intended use followed by identification of all the applicable product standards is vital. The process thus culminates in the design and development file which is a formal document that describes the design history of the medical device.
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Overview Of Medical Device Regulations

As explained in the introduction, the mechanism or system that controls the use of medical devices is called Medical Regulatory body and there are many such bodies covering different geographical regions. The European Union’s regulatory process and the United States FDA process which are the major two regulations will only be covered here as examples to understand the methodology.

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