Design validation, referred to as Design Validation in English usage, is the documented proof that a medical device meets the needs of users and patients, as well as its intended purpose, under real or realistically simulated conditions of use. It is regulated in ISO 13485 Section 7.3.7 and must be carried out according to planned and documented specifications before the product is released for use. Unlike the pharmaceutically oriented validation subjects covered by the existing glossary entry on validation, design validation does not focus on an analytical method, a manufacturing process, or a computer-aided system, but on the product as a whole in its application context. Legally, it supports the demonstration of the general safety and performance requirements according to Annex I of Regulation (EU) 2017\/745. <\/p>\n
The test object is central: ISO 13485 requires that validation be performed on representative products, i.e., products from the initial series, production lots, or demonstrably equivalent samples. Prototypes with different manufacturing processes, materials, or software configurations are not sufficient without justified proof of equivalence. Equally crucial is the replication of actual use: intended user groups with their qualification profiles, operating environment with lighting, noise, hygiene requirements, and time pressure, combination with accessories and other products, reprocessing and reuse, transport, and storage. The validation also includes the information supplied by the manufacturer, particularly labeling and instructions for use, as these are part of the product in terms of its application. Results, deviations, and derived measures are maintained as records. <\/p>\n
ISO 13485 Section 7.3.7 explicitly requires that clinical evaluations or performance evaluations, where applicable regulatory requirements stipulate this, are part of design validation. For medical devices in the European Union, this means that the clinical evaluation according to Article 61 and Annex XIV of Regulation (EU) 2017\/745 is not an isolated approval document, but is methodologically embedded in the design validation; clinical investigations are a possible data source for this, regularly required for implantable products and Class III products. The second fundamental component is usability: the summative evaluation according to IEC 62366-1 tests with representative users whether critical tasks can be performed without safety-relevant use errors, thereby providing validation evidence for the human-product interface. In addition, depending on the product, software validation, reprocessing and compatibility evidence, as well as evidence for aging and shelf life, are required. <\/p>\n
Design verification of medical devices answers the question of whether the development results meet the development inputs, i.e., whether the product was built correctly; design validation answers whether the right product was built, measured against user needs and intended purpose. A product can meet all specifications and still fail validation if the specifications incompletely reflect the needs. Design validation differs from process validation according to ISO 13485 Section 7.5.6 by its subject matter: the latter demonstrates the ability of a manufacturing, cleaning, or sterilization process to reproducibly achieve a result, while the former demonstrates the suitability of the design. It should also not be confused with the validation of computer-aided systems, which concerns the suitability of software used for quality management purposes. <\/p>\n
Design validation and clinical investigations are in a staggered relationship. Before the start of a clinical investigation, verification and the non-clinical parts of validation must be completed to an extent that the exposure of study participants is justifiable; Annex XV of Regulation (EU) 2017\/745 requires corresponding preclinical evidence in the application and notification documents. The clinical investigation itself then provides the validation data that can only be obtained in humans, particularly regarding clinical performance, benefit, and handling in everyday care. <\/p>\n
For study planning, this means that study endpoints must be derived from user needs and the intended purpose, and not solely from technical specifications, and that the product status tested must be representative of the series product. Changes to the product during the study period must be evaluated to determine whether representativeness and thus the usability of the data are maintained. Full-service CROs like Mediconomics support manufacturers and sponsors in planning clinical studies as a validation component, aligning endpoints with user needs and intended purpose, and preparing study results for validation and conformity documentation. <\/p>\n
Can validation be performed on prototypes?<\/strong><\/p>\n Only if the samples are demonstrably equivalent to the series products. ISO 13485 Section 7.3.7 requires representative products, usually initial series or production lots; equivalence must be justified and documented. <\/p>\n Is a clinical investigation always part of design validation?<\/strong><\/p>\n No. A clinical evaluation is required; whether a separate clinical investigation is necessary depends on Article 61 of Regulation (EU) 2017\/745, the risk class, and the robustness of existing data. <\/p>\n When must validation be repeated?<\/strong><\/p>\n In case of changes to design, materials, software, accessories, reprocessing, user groups, or intended purpose, insofar as the change may affect suitability for user needs; the scope must be determined based on risk.<\/p>\n Design validation, referred to as Design Validation in English usage, is the documented proof that a medical device meets the needs of users and patients, as well as its intended purpose, under real or realistically simulated conditions of use. It is regulated in ISO 13485 Section 7.3.7 and must be carried out according to planned […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[24],"class_list":["post-7767","glossary","type-glossary","status-publish","hentry","glossary-cat-medizinprodukte-ivd"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7767","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7767\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7767"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7767"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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