Your existing ERP stays in place
We do not replace Logo, Mikro, Netsis or SAP. Accounting, e-invoicing and statutory processes continue in your current system; we build the medical-specific operational layer that runs alongside it.
INDUSTRY SOFTWARE · HEALTHCARE AND MEDICAL DEVICE MANUFACTURING
From raw-material lot to UDI, we make your medical device production audit-ready and traceable.
In most medical device manufacturers, ÜTS/TİTUBB submissions (Türkiye's medical device tracking systems), ISO 13485 quality records (CAPA, complaints), batch/lot and UDI-DI traceability, calibration and cleanroom records sit outside the ERP — scattered across Excel, paper and external consultants. We build the medical-specific operational software layer that runs alongside your existing Logo, Mikro, Netsis or SAP system, without replacing it.
9 Medical-specific operational modules (ÜTS, eQMS, UDI traceability, DHR...)
4+ Integration with your existing ERP (Logo, Mikro, Netsis, SAP)
UDI End-to-end traceability from raw-material lot to finished-product UDI-DI
100% Source code and data are yours
Does this sound familiar?
The picture we see most often in medical device manufacturing.
If even one of the statements below is yours, you are on the right page.
- The ERP (Logo/Netsis/SAP) holds production and stock, but ÜTS submissions, the eQMS (CAPA/complaints), calibration and cleanroom records sit in separate silos; the same lot data is keyed by hand into 3-4 places, breeding inconsistency and duplicate data.
- ISO 13485 documentation, CAPA and complaint records live in Word/Excel and shared folders; with no electronic approval or audit trail, version and signature history cannot be produced in a TİTCK (Turkish Medicines and Medical Devices Agency) or notified body audit.
- ÜTS/TİTUBB unique-device and lot movement submissions are manual or semi-automatic; keying into the portal takes time, and rejected or missing submissions create fines and market-access risk.
- The full chain from raw-material lot to finished-product UDI-DI is not tracked in a single system; in a recall, finding the affected batches can take days.
- Production tracking largely runs on paper work orders and after-the-fact ERP entry; a real-time DHR (Device History Record) is not compiled automatically, and operator signatures and timestamps are missing.
- The EUDAMED modules that became mandatory in 2026, Basic UDI-DI/EMDN coding and MDR technical file compilation are new to local manufacturers; because the data is not integrated with the ERP/QMS, dependence on consultants and manual effort is high.
- Calibration due dates are tracked in Excel and on wall calendars; deadlines slip, out-of-tolerance impact analysis is impossible, certificates are scattered, and measurement-device traceability cannot be proven in an audit.
- Temperature, humidity, differential-pressure, particle and sterilisation batch records are mostly manual; without continuous monitoring and alarms, deviations are noticed late and validation evidence stays weak.
- Local ÜTS tools do not support ISO 13485/MDR quality processes, while global eQMS platforms do not support Türkiye-specific ÜTS/TİTUBB/SGK submissions; the firm synchronises two separate worlds by hand.
- Supplier deviations (SCAR), incoming material lot acceptance (IQC) and certificate (CoA/CoC) management are not systematic; accountability and root-cause analysis are weak, and incoming quality control leaves no trail.
The sector's software landscape today
Which software do medical manufacturers use today, and where does it break down?
We lay out today's landscape as it is: real tools, real limits. The custom software opportunity begins exactly where these tools end — in the gap between systems.
| Layer | Software in use today | The gap it leaves |
|---|---|---|
| ERP / Accounting (the common base) | Logo Tiger / GO, Logo Netsis, Mikro, SAP Business One and S/4HANA (large scale), DIA, CANIAS ERP, ETA, Zirve | Handles stock, purchasing, sales, finance, e-Fatura/e-İrsaliye (Türkiye's e-invoice and e-dispatch), production orders and serial/lot tracking well; the SME medical manufacturer's backbone is usually Logo or Netsis, with SAP at enterprise level. It does not natively cover ISO 13485 quality processes (CAPA, complaints, design control), Türkiye-specific ÜTS/TİTUBB submissions or MDR/EUDAMED compliance; those gaps are closed with Excel, ÜTS middleware and paper. |
| ÜTS / TİTUBB registration and submissions (mandatory, Türkiye-specific) | TİTCK ÜTS portal (utsuygulama.saglik.gov.tr), DataStil StilÜTS, UBBMED, Evoset ÜTS software, Verimix, MDP Group ÜTS-SAP integration, Logo/Netsis ÜTS integration add-ons | Manages company/certificate/product registration, dealer and unique-device movement submissions and barcode/data-matrix generation. Without ÜTS registration a product cannot be placed on the Turkish market. These tools solve the ÜTS side but are not integrated with ISO 13485/MDR quality processes; the ERP-to-ÜTS submission flow in most firms is still manual or semi-automatic. |
| eQMS / ISO 13485 quality management (global, sector-specific) | Greenlight Guru (dedicated to medical devices), MasterControl, Qualio, Veeva Vault QMS, ETQ Reliance, ComplianceQuest, QT9 QMS, AssurX, Qualityze, SimplerQMS | Strong at document control (SOPs), CAPA, complaints and vigilance, audits, training records, risk management (ISO 14971/FMEA) and design control (DHF). But they are positioned for global scale and budgets, and do not support Türkiye-specific ÜTS/TİTUBB/SGK submissions. Most local SME manufacturers still run on Excel/Word plus shared folders; eQMS adoption is low. |
| MES / production tracking and digital DHR | QT9 (ERP+MES), MasterControl Manufacturing Excellence; in Türkiye, Logo and Netsis production modules, Evoset production tracking and local MES tools | Provides real-time production data, operation timestamps/signatures, consumed-lot records and electronic DHR compilation. Most local manufacturers have no separate MES; production tracking is done with the ERP production module plus paper work orders, and the DHR is retrospective and error-prone. |
| MDR / CE technical file & EUDAMED / UDI | EUDAMED (the EU database), GS1 / HIBCC / ICCBBA (UDI-DI issuing agencies), DataStil EUDAMED management/tracking, MDR consultancy + file tools such as MedikoZ and CROTurk, Greenlight Guru and MasterControl technical file modules | Covers Basic UDI-DI/UDI-DI assignment, EUDAMED actor/device registration (SRN), MDR 2017/745 technical file compilation and EMDN coding. EUDAMED's first modules became mandatory in 2026; because the data is not integrated with the ERP/QMS, the process depends on manual effort and consultants, and the 2027-2028 deadlines add pressure. |
| Calibration & cleanroom / environmental monitoring | QT9 Calibration, GAGEtrak, ProCal; calibration modules inside eQMS platforms (MasterControl, ComplianceQuest); environmental monitoring (EMS/BMS) and data-logger systems; in Türkiye, commonly Excel calibration tables and manual forms plus thermo-hygrometers | Manages calibration schedules, certificate storage, out-of-tolerance impact analysis, cleanroom particle/microbiological monitoring and sterilisation batch records. In most local manufacturers calibration runs on Excel plus a wall calendar and environmental monitoring on manual forms; continuous monitoring and alarms are rare, and records for audits are gathered from scattered sources. |
| Office / auxiliary (the de facto tool) | Microsoft Excel, Word, shared folders, email, WhatsApp (shift/field communication), paper forms and work orders | CAPA and complaint records, lot-tracking tables, calibration due dates, cleanroom forms and ÜTS submission lists are in practice mostly kept here. This is the most widespread real tool — and the starting point of the custom software opportunity. |
Our approach
An operational layer that closes the gap between ÜTS and ISO 13485 — without replacing your ERP.
We keep your existing systems in place and build a medical-specific software layer on top, uniting ÜTS submissions, quality records, UDI traceability and compliance processes in a single flow.
ERP-ÜTS-eQMS bridge
A middle layer that flows lot and product data from the ERP automatically into ÜTS/TİTUBB submissions and quality records. One entry feeds multiple systems; it closes the gap between Türkiye-specific ÜTS and global ISO 13485/MDR.
End-to-end batch/lot and UDI-DI traceability
Raw-material lot, production operation, sterilisation batch and finished-product UDI-DI are traced forwards and backwards in a single panel. A traceability engine that finds the affected batch in seconds during a recall.
Shop-floor data capture and digital DHR
Operator signatures, timestamps and material lot scans via tablet and barcode; the Device History Record is compiled automatically. Paper work orders disappear, and evidence is available instantly in an audit.
ISO 13485 eQMS and compliance records
CAPA, complaints/vigilance, document control, the calibration schedule and cleanroom monitoring in one place — with electronic approval and an audit trail. The core that replaces Excel/Word and shared folders.
Quality and compliance dashboard on one screen
CAPA closure times, complaint trends, calibration due dates, batch rejection rates and ÜTS submission status in a single dashboard. Ready for management and audits — live KPIs without waiting for the end-of-day report.
The systems we build
The right system for every layer of medical manufacturing.
You do not have to build them all at once; we start with the process that hurts most, with the module you need.
API
ERP-ÜTS-eQMS Integration Layer
Two-way data flow between Logo, Mikro, Netsis, SAP and the ÜTS portal. A middle layer that flows lot/product data from the ERP automatically into ÜTS submissions and quality records, ending double entry with a single master dataset.
Detailed page → APIÜTS / TİTUBB Submission Automation
A module that generates unique-device and lot movement submissions automatically from the ERP, prints barcodes/data-matrix codes and raises an instant alert on rejected submissions. Built to work with tools such as StilÜTS, UBBMED and Evoset, or directly with the portal.
Detailed page → QMS
ISO 13485 eQMS / CAPA and Complaints
Document control (SOPs), CAPA, complaints and vigilance, audits, training and risk management — with electronic approval and an audit trail. The right scale for SMEs priced out of Greenlight Guru or MasterControl.
QR
MES Batch/Lot & UDI-DI Traceability Backbone
QR/barcode-based forward and backward tracing from raw-material lot to sterilisation batch and finished-product UDI-DI, with recall simulation. Which lot, which batch, which customer — answered in seconds.
Digital DHR / Production Tracking
Work-order-based production, operation timestamps and signatures, consumed material lot records and electronic Device History Record compilation. You see the state of production on the floor in real time — without looking at paper.
Detailed page → QMS
IoT Calibration & Equipment Management
Calibration schedules for measurement/test equipment, due-date reminders, out-of-tolerance impact analysis and a certificate archive — integrated with the eQMS. Auditable equipment management that replaces Excel and the wall calendar.
Cleanroom / Sterile Environment Monitoring
Real-time data from temperature, humidity and differential-pressure sensors, alarms on threshold breaches, digitalised sterilisation batch records and automated validation reporting. It removes the manual form burden.
Detailed page → QMS
BI MDR/CE Technical File & EUDAMED Assistant
Basic UDI-DI/EMDN coding, a technical file checklist and automatic compilation of the data destined for EUDAMED from your ERP/QMS. It puts preparation for the 2027-2028 deadlines on a systematic footing.
Quality & Management Dashboard
CAPA closure times, complaint trends, calibration due dates, batch rejection rates and ÜTS submission status on a single screen. Live KPIs and reporting, ready for management and audits.
Detailed page → Integration with your existing ERP
Digitalise without throwing your systems away.
You may be running Logo, Mikro, Netsis, SAP or another ERP; you do not have to replace any of them. Pan Innovation House builds the medical-specific operational layer that runs alongside these systems and your existing ÜTS software (StilÜTS, UBBMED or Evoset, for example). Accounting and statutory processes stay in your current ERP, while ÜTS submissions, ISO 13485 quality records, batch/lot and UDI-DI traceability, calibration and the cleanroom side are managed with a single master dataset — and double data entry ends.
Our integration approach →- You do not have to replace Logo, Mikro, Netsis, SAP or any other ERP.
- Accounting, e-invoicing and statutory processes stay in your existing ERP.
- ÜTS/TİTUBB submissions, ISO 13485 quality records, UDI traceability and calibration are managed in the custom operational software.
- Product, lot, UDI-DI and device data is held in one master dataset, synchronised two-way with the ERP and the ÜTS software.
- Not a one-off migration; continuous, automatic and controlled integration.
Outcomes
What changes in medical manufacturing once you digitalise?
- End-to-end batch traceability from raw-material lot to finished-product UDI-DI
- The scope of affected batches identified in seconds during recalls and audits
- ÜTS/TİTUBB submissions generated from the ERP automatically, accurately and on time
- ISO 13485-compliant CAPA and complaint records with electronic approval and an audit trail
- A digital DHR compiled automatically with operator signatures and timestamps
- Paper work orders retired, and instantly accessible evidence in audits
- No missed calibration deadlines, and out-of-tolerance impact analysis made possible
- Cleanroom and sterilisation records digitalised with continuous monitoring and alarms
- Reduced dependence on consultants and manual effort in MDR/EUDAMED and UDI compliance
- Excel, Word and shared-folder islands removed, and double data entry ended
Process
A realistic five-stage path that begins with discovery.
- 01
Initial consultation
1 weekWe listen to your needs, your existing ERP and ÜTS setup, and your ISO 13485 and MDR/EUDAMED compliance priorities. We clarify expectations and draw the right scope together. No obligation.
- 02
On-site discovery and process analysis
1-2 weeksWe come to your facility and observe production, the cleanroom, quality (CAPA/complaints), calibration, ÜTS submissions and the UDI/traceability flow in place. We map your existing ERP, ÜTS software and Excel arrangements.
- 03
Digital transformation roadmap
1 weekWe present a clear roadmap showing which module goes live first, ranked by benefit and priority. The quickest wins are usually in ÜTS submission automation and batch/UDI traceability; a phased plan that fits the shop floor.
- 04
Module-based software development
Per moduleStarting with the process that hurts most, we develop the modules one by one and test them on shift. We build the integration with the ERP and the ÜTS software and deliver visible progress at every step; no surprises.
- 05
Go-live, training and support
OngoingWe train the production, quality and regulatory teams, take the system live and stay at your side. As regulation (MDR/EUDAMED) changes and new needs arise, the software grows with you.
Why Pan Innovation House?
Not a software vendor, but a digital transformation team that knows the shop floor.
A local team that knows Gaziantep and its organised industrial zone (OSB)
We know how highly regulated production operates under the weight of ÜTS, ISO 13485 and MDR. We are not remote from the realities of the OSB and the shop floor.
A software approach that understands the medical floor and its regulation
We design by talking through lots, sterilisation batches, cleanrooms, the DHR and the ÜTS/UDI process. We fit the software to the shop floor and the regulation — not the shop floor to the software.
Not an off-the-shelf package — a solution built for your business
We do not force you into a mould. A consumables manufacturer and an active implant manufacturer have different needs; the software is built around your processes, and you never pay for modules you do not use.
Digitalisation without replacing your ERP
We protect your existing Logo/Mikro/Netsis/SAP investment and build on top of it. We do not put you through a risky, expensive and drawn-out ERP migration.
A view that treats ÜTS and ISO 13485/MDR as one whole
Not just production; we treat ÜTS/TİTUBB submissions, the eQMS, UDI traceability, calibration, the cleanroom and EUDAMED compliance as a single whole.
A realistic project model that starts with on-site discovery
We come, see and listen first. We measure before we promise; we present a workable plan, not inflated claims. 100% of the source code and data stays with you.
Frequently asked questions
Common questions about Healthcare and Medical Devices software.
Do we need to replace our existing Logo / Mikro / Netsis / SAP system?
No. Your existing ERP and accounting system stays in place. We build a medical-specific layer that runs alongside it, managing ÜTS submissions, ISO 13485 quality records, UDI traceability and calibration processes; where needed, we provide two-way data integration between the two systems.
Can this software make ÜTS/TİTUBB submissions automatically?
Yes — this is one of the quickest wins. We generate unique-device and movement submissions automatically from the lot and product data in your ERP, print barcodes/data-matrix codes and raise an instant alert on rejected or missing submissions. We set it up to work with your existing ÜTS software (StilÜTS, UBBMED or Evoset) or directly with the TİTCK ÜTS portal; manual entry and the risk of fines both fall.
Do we need to buy a separate eQMS for ISO 13485?
Global eQMS platforms such as Greenlight Guru, MasterControl and Qualio are powerful but costly, and they do not support Türkiye-specific ÜTS/TİTUBB/SGK submissions. We build a quality layer at SME scale that manages document control, CAPA, complaints/vigilance, calibration and cleanroom records with electronic approval and an audit trail. If you already have a global eQMS, we can integrate with it too.
Does batch/lot and UDI traceability really pay off in a recall?
Yes — that is the core purpose. Because the raw-material lot, production operation, sterilisation batch and finished-product UDI-DI are linked together, we provide forward-and-backward traceability with recall simulation that shows, in seconds, which batches are affected by a complaint or recall and which customers received them.
Can we drop paper work orders and move to a digital DHR?
Yes. Operator signatures, timestamps and consumed-material lot scans are captured via tablet and barcode; the Device History Record is compiled automatically. Paper work orders and after-the-fact ERP entry disappear, and in an audit you get instantly accessible electronic evidence instead of retrospective searching.
How do you help with the MDR/CE technical file and EUDAMED compliance?
EUDAMED's first modules became mandatory in 2026, and the 2027-2028 deadlines add pressure. We build a compliance assistant that handles Basic UDI-DI/UDI-DI and EMDN coding, a technical file checklist, and automatic compilation of the data destined for EUDAMED from your ERP/QMS. It gathers the data needed for SRN/actor and device registration in one place and reduces dependence on consultants and manual effort.
Can you digitalise cleanroom and sterilisation records as well?
Yes. We collect real-time data from temperature, humidity and differential-pressure sensors, raise alarms on threshold breaches, digitalise sterilisation batch records (EO/steam/gamma dose) and automate validation reports. The manual form burden disappears, deviations are noticed immediately rather than late, and your validation evidence for audits gets stronger.
Do you also serve medical device manufacturers outside Gaziantep?
Yes. Our base is Gaziantep and we know the manufacturing industry in its OSB closely; but we also serve medical device and consumables manufacturers in the surrounding provinces and across Türkiye. We plan the schedule for on-site discovery and the project together.
Let us start together
Let us see your production first — then let's talk.
In an on-site discovery we examine your production, cleanroom, quality, calibration, ÜTS submission and UDI/traceability flow in place; together we determine which module will bring you the fastest benefit. No obligation.
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