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Medical Devices

SAP solutions for Class I–III medical device manufacturers under MDR, FDA 21 CFR and ISO 13485.

Quality systems for
life-critical devices.
Medical device manufacturers operate under some of the strictest regulatory frameworks in the world. MDR, FDA 21 CFR Part 820, ISO 13485 — each demands rigorous quality systems, complete traceability and controlled change management. SAP is the platform that makes this manageable at scale.

ZDS brings both SAP expertise and deep understanding of medical device quality requirements. We configure SAP QM, validate systems to the required standards and integrate with your PLM and LIMS environments.

From Class I consumables to Class III implantables, we deliver SAP solutions built for device manufacturing.

Medical device solutions
Regulatory-ready capabilities
01
ISO 13485 QMS
SAP QM configuration aligned to ISO 13485 quality management system requirements.
02
UDI / Traceability
Unique Device Identification management, EUDAMED integration and full batch/serial traceability.
03
Design Control
Integration of PLM design history files with SAP production and quality processes.
04
Post-Market Surveillance
Complaint management, vigilance reporting and FSCA workflow management in SAP.
05
Computer System Validation
IQ/OQ/PQ validation of SAP systems to FDA 21 CFR Part 11 and EU Annex 11 requirements.
06
Supplier Quality
SAP QM supplier evaluation, incoming inspection and approved supplier list management.
Build a compliant device QMS in SAP.
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