QA Documentation Package from Matrix eIFU
A comprehensive, ready-made QA documentation package to support your internal validation and regulatory compliance activities — no need to build vendor qualification documentation from scratch.
For taking a demo with our team.
The challenge
Qualifying a new software vendor takes serious time and resource
- Vendor qualification is heavy liftingSupplier audits, validation testing, and documentation review all take internal Quality time.
- Notified bodies expect thorough documentationGeneric vendor documentation rarely meets medtech-specific expectations.
- GDPR adds another layerData processing agreements need to be in place and reviewed before go-live.
Our solution
A ready-made documentation package, built for medtech expectations
- Complete validation documentationV&V protocols and reports provided, ready for review and approval.
- Supplier qualification supportDocumentation ready to support vendor approval in your QMS.
- Risk and security documentation includedISO 14971 aligned risk management and full security documentation.
Core capabilities
Ready-made documentation that meets notified body and inspector expectations.
Validation documentation, ready to go
Software validation documentation, including V&V protocols and reports, provided in full.
Software validation documentation (V&V protocols and reports)
Risk management documentation aligned with ISO 14971
Communication plans for platform changes
Supplier qualification support
Documentation ready to support vendor approval within your own QMS.
Supplier qualification documentation for vendor approval
Security and infrastructure documentation
Data processing agreements for GDPR compliance
Faster time to compliance
Reduces the internal validation burden significantly.
Meets notified body and regulatory inspector expectations
Limits internal validation costs
Accelerates time to compliance
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