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Solutions for Medical Device Quality Control Teams

QC Without Delays, Errors, or Paper Trails.

With Regtech, Quality Control (QC) teams don’t just check quality, they lead it. From automated AQL sampling to interlinked calibration tracking, our system ensures that your quality control is proactive, traceable, and audit-ready at all times.

Automated Inspection Sampling

Regtech auto-selects inspection samples based on batch size and preferred sampling method (Random/AQL/ Percentage):

  • Eliminates human error in sampling
  • Ensures consistency across all inspections
  • Built-in compliance to international standards (ISO 2859-1)
Every sample size calculated right — every single time.

Inspection Data Auto- Linking

  • During incoming inspection, all relevant inspection parameters are automatically populated per material, improving accuracy and reducing repetition. All you need to do is enter your observations, and the system will give the final result as per pre-defined criteria.
  • Inspection parameters common for In-process as well as Finished product testing can directly be identified and replicated without repetitive efforts during execution.
Inspect faster, decide smarter — without re-entering data.

Calibration Reminders – Always On Time

Stay ahead of compliance requirements:

  • System alerts you before calibration due dates. Avoids risks of non-compliance and equipment errors.
  • Let Regtech remember the dates, so you can focus on quality.
Never miss a calibration. Never risk a finding.

Connected with Production in Real-Time

  • QC is notified to initiate review and inspection
  • BMR splits and batch size changes reflect instantly
  • Non-conforming items are auto-logged for further action
  • Your QC processes are synchronized with production in one integrated system. No back-and-forth.​​
QC moves at the speed of production — not behind it.

Connected to Stores – Real-Time Transfer

Once QC approves the batch:​

  • Finished Goods are auto-transferred to FG Register in Stores
  • Inventory updates are automatic, traceable, and audit-ready.
From QC approval to FG inventory, automatically.

Instant Non-Conformance Tracking

When non-conforming units are logged by Production:

  • Regtech automatically flags them in the Non-Conformance Register
  • QC can categorize and initiate appropriate actions — Rework or Reject Close the quality loop with zero delay.
  • Integrated feedback loop with Production & QA
Non-conformances don’t wait — neither does Regtech.

Centralized Quality Records

All test results, calibration certificates, and inspection logs:

  • Stored securely in one platform
  • Accessible anytime, with complete traceability
Be ready for any audit — even the surprise ones
  • Role-based access control for inspection teams and auditors
One system. One truth. One quality outcome.

From batch inspection to store release — Regtech connects the dots for true operational quality.