Literature DB >> 19964134

Medical device development.

Dorin Panescu1.   

Abstract

The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

Mesh:

Year:  2009        PMID: 19964134     DOI: 10.1109/IEMBS.2009.5333490

Source DB:  PubMed          Journal:  Conf Proc IEEE Eng Med Biol Soc        ISSN: 1557-170X


  3 in total

Review 1.  Impact of Health Care Reform on Technology and Innovation.

Authors:  Preethi Kesavan; Christopher J Dy
Journal:  Hand Clin       Date:  2020-05       Impact factor: 1.907

2.  Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review.

Authors:  Petra Marešová; Blanka Klímová; Jan Honegr; Kamil Kuča; Wan Nur Hidayah Ibrahim; Ali Selamat
Journal:  Front Public Health       Date:  2020-07-30

Review 3.  Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs).

Authors:  Jennifer C Goldsack; Andrea Coravos; Jessie P Bakker; Brinnae Bent; Ariel V Dowling; Cheryl Fitzer-Attas; Alan Godfrey; Job G Godino; Ninad Gujar; Elena Izmailova; Christine Manta; Barry Peterson; Benjamin Vandendriessche; William A Wood; Ke Will Wang; Jessilyn Dunn
Journal:  NPJ Digit Med       Date:  2020-04-14
  3 in total

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