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Journal article

Evaluating the presence of software-as-a-medical-device in the Australian Therapeutic Goods Register

Abstract:

In recent years, medical device regulatory bodies have recognised software-as-a-medical-device (SaMD) as a distinct subgroup of devices. The field of SaMD has been rapidly evolving and encompasses a range of different digital solutions. Many organisations have now started to look into digital healthcare, as a way to solve key global challenges. However, there remains uncertainty regarding how many of these SaMD products are entering the market and to what extent these systems achieve a desire...

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Publication status:
Published
Peer review status:
Peer reviewed

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Files:
Publisher copy:
10.3390/prosthesis3030022

Authors


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Role:
Author
ORCID:
0000-0001-8863-6772
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Institution:
University of Oxford
Department:
ENGINEERING SCIENCE
Sub department:
Engineering Science
Role:
Author
ORCID:
0000-0001-7306-2630
National Institute for Health Research More from this funder
Publisher:
MDPI Publisher's website
Journal:
Prosthesis Journal website
Volume:
3
Issue:
3
Pages:
221-228
Publication date:
2021-08-24
Acceptance date:
2021-08-20
DOI:
EISSN:
2673-1592
Language:
English
Keywords:
Pubs id:
1192373
Local pid:
pubs:1192373
Deposit date:
2021-08-25

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