Faster launches
Get compliant products to market sooner with validated processes and quality systems built into your SAP foundation.
Life Sciences: Medical Devices
Compliant Devices, Connected From Design to Service
From regulatory clearance to field service and post-market surveillance, Oraya® helps medical device manufacturers launch compliant products sooner and manage them through their whole lifecycle on one integrated SAP platform.
Fast launches need compliance designed in from day one
Device makers are under constant pressure to innovate quickly while staying fully compliant across every product, every revision and every unit installed in the field.
Running a device business is operationally demanding. Products travel through hospitals, distributors, field representatives and consignment locations. They are serviced, calibrated, revised and eventually retired. Managing that entire lifecycle compliantly, at scale and across global markets, calls for systems built specifically for regulated environments.
Oraya® combines life sciences experience with proven SAP delivery methods to help device manufacturers of every size, from focused single-product firms to diversified global portfolios, build the operational backbone they need to compete and comply.
Outcomes we deliver
Stronger traceability
Keep unique device identification (UDI) traceability intact from manufacturing and labeling through distribution, implantation and post-market surveillance.
Revision and change control
Manage product revisions, engineering changes and version history without losing the link to earlier configurations.
Real-time visibility
See distributed inventory in real time, including consignment stock, field representative inventory and hospital locations.
Service operations
Support field service with integrated service management, repair tracking, calibration records and loaner device management, including device-as-a-service and subscription models that tie service contracts, consumables and compliance tracking together on one platform.
Simpler quality processes
Handle complaints, adverse event reporting and corrective and preventive action (CAPA) management on one connected platform.
New markets
Expand into new regions with regulatory reporting frameworks that support global compliance requirements.
Validation-ready implementation
Oraya® runs every SAP program with a structured validation approach designed for regulated environments, aligned with GAMP 5 guidance and the FDA’s risk-based Computer Software Assurance (CSA) model.
Our process includes:
Validation plan
A validation plan scoped to your products, sites and regulatory context.
IQ/OQ/PQ protocols
Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols and execution.
Traceability matrix
A complete traceability matrix that ties each requirement to its test evidence.
Continuous validation
Ongoing validation support through SAP releases, upgrades and configuration changes, so your validated state stays current instead of being proven once.
We partner with an experienced life sciences validation specialist to support clients from initial validation through long-term compliance.
SAP capabilities for medical devices
Oraya® supports every SAP Cloud ERP deployment model, helping regulated clients select the architecture that fits their compliance posture, IT strategy and timeline. SAP gives medical device companies the integrated platform they need to handle both the compliance demands and the operational complexity of a distributed, regulated product lifecycle:
- Design history file (DHF), device master record (DMR) and device history record (DHR) management that keeps the complete documentation chain, from design controls and development through manufacturing and post-market, with full audit trails and electronic signatures that support 21 CFR Part 11
- Data integrity controls aligned with ALCOA+ principles (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available), a continuing focus for regulators worldwide
- Product lifecycle and change management to govern engineering changes, revision history and regulatory submissions across product generations
- Integrated quality management spanning incoming inspection, in-process controls, nonconformances, CAPA and post-market complaint handling
- Quality management system configuration aligned with ISO 13485 and the FDA’s Quality Management System Regulation (QMSR), which brings 21 CFR Part 820 into line with ISO 13485 as one global quality standard
- EU MDR and IVDR support, including EUDAMED and device registration and UDI-DI/UDI-PI requirements, for manufacturers selling in or expanding into the European market
- UDI generation, labeling and serialization that meet FDA and global track-and-trace requirements
- Advanced warehouse and inventory management for multi-location distribution, including consignment, field and customer-site stock
- SAP Field Service Management for service contracts, preventive maintenance, repair workflows and calibration tracking
- Connections to the platforms you already run, including MES and LIMS, keeping compliant data flowing across the full technology stack instead of replacing tools that already work
