The use of predetermined change control plans to enable the release of new versions of software as a medical device
This work is novel in the gathering of meaningful input from experts, practitioners, and regulatory professionals within the SaMD industry located in the EU, UK, and US on the value and need for PCCPs. This study has implications for practice and policy as it can inform SaMD guidance and legislation.
Authors
- Olivia McDermott (ORCID: https://orcid.org/0000-0001-5714-4601)
- Jacques Andre DuPreez
Institutions
- Ollscoil na Gaillimhe – University of Galway (IE)
Publication Details
- Journal
- Expert Review of Medical Devices
- Published
- 2025-02-18
- DOI
- https://doi.org/10.1080/17434440.2025.2468787
- Citations
- 10
- Primary Topic
- Quality and Safety in Healthcare
- Type
- article
- Field-Weighted Citation Impact
- 35.29