Guarantee the compliance of your medical device software with the IEC 62304 standard
Introduction If you are developing a medical device that uses software, or if you are developing a SaMD (Software as a Medical Device),...
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VALIDATION
ISO 13485, IEC 62304, 21CFR Part 11 - ERP - GED - Quality - LIMS - GAMP5
V-Cycle- Agile - DevOps
ATLASSIAN
OUR AREAS OF EXPERTISE
Jira - Confluence - Service Management - Bitbucket
Document Management
Quality - Design Control
Requirements Management
Agile Systems Engineering
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PRODUCT LIFE CYCLE
3DExperience, Systems Engineering
SERIALIZATION
Alert management, UDI
ELECTRONIC SIGNATURE
eIDAS - 21CFR Part 11
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