REFERENCE
Technical Project Manager (MDR)
Worked as a Technical Project Manager in a support role for establishing Software as a Medical Device development processes for Agile development teams in a partner project with Clinipower Finland Oy.
Client
Year
2022
Client site
Details
Project consisted of defining following Software as a Medical Device processes and work instructions using Agile principles according to ISO 14971:2019, ISO 13485:2016 and IEC 62304 2006/A1:2015.
- Defect Management process
- Software Validation process
- Change Management process
Documentation consisted of process documentation and diagrams in Confluence, plus related Jira issue definitions and workflows.
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