A CRITICAL EVALUATION OF THE ROLE OF PRODUCT DEVELOPMENT IN THE REGISTRATION OF MEDICAL DEVICES IN EUROPEAN UNION

Product /development /refers /to /the /transformation /process /of /an /idea /into /a /product /or service. /It /can /be /applied /to /any /sector, /but /special /attention /must /be /given /to /each industry /particularities. In /the /case /of /medical /devices, /the /development /process /should /consider /the /multiple /definitions /of /the /term, „medical /device", /a /vast /regulatory /framework /as /well /as /numerous /organizations /that /evaluate /the /devices" /safety /and /effectiveness /before /entering /the /market.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-03-23
DOI
https://doi.org/10.5281/zenodo.15072475
Primary Topic
Quality and Safety in Healthcare
Type
article
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article

A CRITICAL EVALUATION OF THE ROLE OF PRODUCT DEVELOPMENT IN THE REGISTRATION OF MEDICAL DEVICES IN EUROPEAN UNION

Zenodo (CERN European Organization for Nuclear Research)
Quality and Safety in Healthcare
article

A CRITICAL EVALUATION OF THE ROLE OF PRODUCT DEVELOPMENT IN THE REGISTRATION OF MEDICAL DEVICES IN EUROPEAN UNION

article en

Abstract

Product /development /refers /to /the /transformation /process /of /an /idea /into /a /product /or service. /It /can /be /applied /to /any /sector, /but /special /attention /must /be /given /to /each industry /particularities. In /the /case /of /medical /devices, /the /development /process /should /consider /the /multiple /definitions /of /the /term, „medical /device", /a /vast /regulatory /framework /as /well /as /numerous /organizations /that /evaluate /the /devices" /safety /and /effectiveness /before /entering /the /market.

Zenodo (CERN European Organization for Nuclear Research)
Industry, innovation and infrastructure
Openalex Percentile: Top 31%
Quality and Safety in Healthcare
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A CRITICAL EVALUATION OF THE ROLE OF PRODUCT DEVELOPMENT IN THE REGISTRATION OF MEDICAL DEVICES IN EUROPEAN UNION · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS