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Stepping in to support Saluda Medical’s Jira validation project
Sanofi is one of the world’s top 10 pharmaceutical companies and part of the organization’s strategy is prioritizing agile working practices and embracing an agile…
How we Saved a medical device company time, compliance headaches and money
For international health industry companies, ensuring regulatory compliance is difficult. Add into the mix an outdated paper-based Quality Management System (QMS), and...
Digitising paper QMS & ensuring ISO-27001 compliance
The challenge of digitising paper QMS An efficient quality management system (QMS) is the lifeblood of any company in the health industry. Failure to meet strict...
“Turning complex quality processes into simple, effective solutions.”
What our customers
are saying
“When developing high-risk products, you need a high level of reliability and security. If the underlying data is properly controlled and can be retrieved with queries, then a large part of the documentation for FDA approval literally creates itself.”
Richard Koch
SaMD IEC 62304 Consultant Koch SaMD
Lee Pfortmiller
As part of a Semiconductor company designing products which meet stringent automotive compliance standards, having a Jira live search on a Confluence page does not meet our traceability needs. Jira snapshots for Confluence bridges the gap between the flexibility of Jira and the traceability requirements of our customers. We take snapshots at various parts of the design cycle to ensure a fixed design target when needed and the ability to update when new versions are started. I must also praise their customer support. They were responsive to my suggestions for improvement and gave me an even better product.”
Stephen Ellwood
Principal Systems Architect EPSG/CSD/NTPG
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