Software for medical technology
Process reliability that saves lives.In medical technology, faulty processes are not a matter of quality but of patient safety. weasl digitizes manufacturing and testing processes, ensures ISO 13485-compliant documentation, and creates the complete audit trail required by Notified Bodies, the MDR, and the FDA.
Leading companies rely on weasl
Handwritten or Excel-based SOPs no longer pass FDA inspections. weasl centrally manages standard operating procedures—in compliance with ISO 13485 and MDR change control requirements. Employees always work with the most recently approved version.
Audit-compliant version control with a complete change history and approval records
Configurable n-eyes approval workflow for SOPs, work plans, and test procedures
Immediate transparency regarding which orders are affected by a change
Digital signatures of the persons performing and verifying the work—tamper-proof and time-stamped
weasl links employee qualifications directly to process approvals and ensures that only personnel who have received verifiable training perform quality-critical tasks—all of which is fully documented for the next inspection.
Employees can only view tasks and steps for which they are qualified
Digital signatures for quality-critical steps as proof of personal execution
Training certificates generated automatically from work records
Step-by-step guidance with images, videos, and validated test criteria minimizes process deviations
weasl generates documentation confirming that each individual product was manufactured in accordance with the Device Master Record (DMR) as an automatic byproduct of daily operations—without the need for manual post-processing.
Automatically generated DHR, including all manufacturing and inspection steps, with timestamps and signatures
Complete UDI traceability of all materials, batches, and components used
Dynamic Audit Steps: The scope of the audit is automatically determined based on the risk class and customer requirements
Export of customizable logs – audit-ready for Notified Bodies and the FDA
weasl makes feedback from the production floor directly actionable: What your employees observe on the production floor is recorded in a structured manner and fed directly into the CAPA process. This allows you to establish a system that not only corrects errors but also systematically addresses their root causes — in accordance with ISO 13485.
Real-time view of order progress, variances, and rework rates by product
Deviations and feedback go directly into QM
Fault Data Collection Categorized by Error Type for Trend and Risk Analyses
Digital Shift Handoff: Ensure that open variances, ongoing orders, and process anomalies are properly handed off
Create work instructions with images, videos, CAD files, and PDFs easily and without any IT knowledge.
Any changes to SOPs and work plans go through a configurable dual-review process with a complete change history.
Required fields, threshold values, and validity checks prevent incorrect entries from passing through the process.
Bidirectional data exchange with SAP, Hydra, and other systems via REST API.
You can connect torque wrenches, scanners, scales, and test towers directly via OPC UA or MQTT.
DHR is produced continuously as a byproduct of manufacturing.
Structured worker feedback and root cause analysis provide the input for CAPA processes.
Keep track of order progress, causes of disruptions, and production times at all times.
Eduard Daoud
Chief Revenue Officer
