Mobile Diagnostic Systems
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2014-11-12 publication

Mobile Diagnostic Systems Standardization Roadmap

The objective of the German Mobile Diagnostic Systems Standardization Roadmap is to introduce solutions for the technological, economical and regulatory challenges in order to successfully integrate mobile diagnostics systems into society and provide orientation for the future developments in this segment.

Core topics of the standardization roadmap

Mobile diagnostics systems have to be consumer-friendly and usable and be able to be easily integrated into existing structures, environments and processes. To take the significance of mobile diagnostics systems in the application field of POCT (point-of-care testing) into account in the future, the standardization roadmap addresses important topics in this field.

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Janina Laurila-Dürsch
Mobile Diagnostic Systems Standardization Roadmap

The core and cross-sectional topics of the Mobile Diagnostics Systems Standardization Roadmap include, among others, the analysis of technical and statutory framework conditions as well as the status quo of applicable standards and the presentation of key technologies required to manufacture such systems. Potential areas of use of mobile diagnostics systems and relevant interest groups are also illustrated.

The recommendations in this standardization roadmap provide an important orientation for future mobile diagnostics systems in the regulatory and normative environment. They are necessary for the successful establishment of mobile diagnostics systems and thus also promote Germany as a location for medical technology.

About the objective and significance of the standardization roadmap

The objective of standardization roadmaps is to inform the stakeholders in the respective subject area of important basic requirements and assist them in meeting them. To achieve this, standardization roadmaps provide an overview of the respective technology topic, in this case mobile diagnostic systems, and the related standardization landscape and its organizational and content-related further development.

For mobile diagnostic systems, standardization roadmaps also allow for the systematic processing of convergent technologies (complex cross-committee topics) and act as a basis for discussion and exchange between the experts from various domains (e.g. automotive, safety, energy). They thus provide for better understanding because they provide all of the participants the same foundation and offer new committee members a subject-related introduction.

Particularly with respect to important subject areas like mobile diagnostic systems, standardization roadmaps emphasizes the need for early development and the significance of the topic of full consensus standardization.

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