Build a device manufacturing system around your serial numbers, your inspections and your complaints.
A device maker answers for every unit it ships. When a hospital reports a fault, the first question is which unit it was and what went into it.
That answer sits in several places: purchase records for the parts, a traveller on the shop floor, an inspection sheet and a dispatch register. Joining them by hand is slow work.
A system built at GullySystem would give each lot and each serial number one record. Parts, process, inspection, shipment and service would be added to it as they happen.
Device makers a system can be built for.
A maker of stainless steel instruments, a maker of beds and a maker of disposable syringes have little in common on the floor. They share the need to trace what was made and who received it.
- Surgical instrument manufacturers
- Hospital equipment manufacturers
- Hospital furniture and bed makers
- Medical disposables makers
- Syringe and needle plants
- Diagnostic equipment manufacturers
- Test kit manufacturers
- Orthopaedic implant manufacturers
- Dental product manufacturers
- Medical plastics moulders
- Electronic medical device makers
- Sterile packaging converters
- Rehabilitation equipment makers
- Contract device manufacturers
The modules, and what each one covers.
Nothing here is a fixed package. Each module is built, left out or changed to match how your organisation already works.
The device master record
Each device model carries its drawings, bill of materials, process steps and inspection plan, all versioned.
- Model, variant and size
- Drawing and revision
- Bill of materials by revision
- Process route
- Inspection plan
- Packaging and labelling specification
- Instructions for use version
- Software or firmware version
- Approved change history
- Regulatory file reference
Parts, materials and suppliers
Purchased parts are recorded by lot, with the supplier’s papers attached.
- Approved supplier list
- Material certificate per lot
- Incoming inspection
- Raw material grade
- Biocompatibility papers where needed
- Supplier performance
- Nonconforming material
- Purchase order and receipt
- Return to supplier
Production orders and travellers
A traveller follows the lot through the shop, and every station signs what it did.
- Production order from a sale or stock plan
- Traveller with operations
- Operator and machine
- Lot and serial number assignment
- Quantity in and out at each station
- Scrap and rework record
- Time at each operation
- Held and released status
- Line clearance
Machining, moulding and assembly
The floor differs by product. The system records the process that the plant actually runs.
- Turning, milling and grinding of instruments
- Polishing and passivation
- Injection moulding with mould and cavity
- Welding and fabrication for equipment
- Electronic assembly and wiring
- Cleanroom assembly
- Tool and mould life
- Process parameter sheets
- Operator training status
Inspection and testing
Inspectors work to a plan, and a unit that fails goes into a held area.
- Incoming, in-process and final inspection
- Gauge and instrument used
- Measured values against tolerance
- Functional and leak tests
- Electrical safety test results
- Sample size by lot size
- Nonconformance raised from a result
- Release by authorised inspector
- Test fixtures register
Test reports are attached to the serial number, so a unit’s results can be read years later without searching a folder.
Sterilisation and special processes
Some steps are done by a third party and some in the plant. Either way the lot cannot ship until they are complete.
- Cleaning and packing before sterilisation
- Sterilisation lot and method
- Outside processor and delivery note
- Cycle record attached
- Biological indicator result
- Residual checks
- Return and reconciliation
- Re-sterilisation limits
Calibration and equipment
Measuring instruments and test rigs are used only while their calibration is current.
- Instrument register
- Calibration due dates
- Certificates attached
- Out-of-tolerance impact on past lots
- Maintenance plan
- Cleanroom monitoring records
- Environmental logs
- Quarantine of overdue instruments
Nonconformance and corrective action
Quality teams see repeated faults across lots, suppliers and stations.
- Nonconformance report
- Disposition: use, rework, scrap or return
- Root cause analysis
- Corrective and preventive action
- Effectiveness check
- Link to supplier
- Link to complaint
- Open items by age
Labelling, unique identification and packing
A wrong label can mean a recall. Label content is generated from the master record.
- Label template by model
- Unique device identifier data
- Lot, serial and expiry on the label
- Reconciliation of labels used
- Carton and shipper packing
- Instructions inserted
- Packing list by serial number
- Reprint control
Finished goods and shipment
Each shipment lists the serial numbers or lots sent and the customer who received them.
- Stock by lot and status
- Order from a hospital or distributor
- Pick by serial number
- Tax invoice
- Delivery and installation note
- Export documents
- Consignee record
- Serials delivered by customer
Complaints and field safety
A complaint opens against a serial number and pulls its production history with it.
- Complaint intake
- Unit identified by serial or lot
- Production and inspection history
- Investigation record
- Reportability decision
- Field correction or recall
- Customers reached
- Closure and trend by model
Installation, service and spares
Equipment in hospitals needs installation, service visits and replacement parts for years.
- Installed base register
- Installation report and sign-off
- Warranty and service contract
- Preventive visit schedule
- Service engineer assignment
- Spare parts issue
- Repair job card
- Calibration of installed equipment
- Service history by serial number
Distributors, tenders and hospital accounts
Many devices sell through distributors and public tenders, each with its own paper.
- Distributor and dealer master
- Territory and price list
- Tender record and bid security
- Delivery against tender schedule
- Hospital account ledger
- Consignment stock at hospitals
- Sample and demonstration units
- Credit notes and returns
One connected workflow, end to end.
Every stage below can sit in one system, so nobody re-enters what the last stage already captured.
- Design transfer
- Supplier parts
- Incoming inspection
- Production order
- Machining or moulding
- Assembly
- Inspection and testing
- Sterilisation
- Labelling and packing
- Release
- Shipment
- Service and complaints
You do not have to replace everything at once.
Each phase is usable on its own, so the system earns its place before the next part is built.
- 1
Master records and incoming parts
The device master record, bills of materials, supplier lots and incoming inspection results, versioned from the start.
- 2
Production and inspection
Orders, travellers, serial numbers, process records, inspection results and nonconformance on one lot record.
- 3
Shipment, complaints and service
Labels, release, dispatch by serial number, complaint investigation, installed base and service visits.
- 4
Distributors and reporting
Distributor and tender records, trend reports and links to the test rigs and label printers on the floor.
How a build actually runs.
- 01
Follow one unit
We pick a single serial number and trace it from parts receipt to the hospital, noting every place its record changes hands.
- 02
Read the quality manual
Your procedures say what must be recorded. The design starts from them rather than from a template.
- 03
Separate the products
An implant, a bed and a syringe need different travellers, so each family gets its own screens.
- 04
Build traceability first
Lot and serial records come before dashboards, since every later report depends on them.
- 05
Try one product family
A single family runs on the system next to the existing records until the two agree.
- 06
Document as built
Specifications and test evidence are kept in a form your quality team can use for its own review.
- 07
Extend gradually
More families, service and distributor records are added after the first release has settled.
What you bring, and when.
The build moves at the speed of the answers. These are the things we ask for, in the order we ask.
- 01
Device master record, travellers and calibration logs
Share the device master record, a production traveller, a calibration log and a complaint file. Labelling samples belong with them. They reflect the quality system as practised.
- 02
Quality, production and regulatory
The quality head, a production lead and the regulatory person look at screens in their area. Shop habit may differ from the quality manual. The quality head decides.
- 03
Batch release rights, nonconformance classes and retention
Who may release a batch, how nonconformances are classed and how long records are kept need decisions as modules are developed. Reviewers from that area try the result.
- 04
Lot histories, supplier approvals and open complaints
Serial and lot histories of devices already shipped, supplier approvals and open complaints are loaded. Test equipment that outputs readings is linked where possible. The quality head approves.
Systems we can put together for you.
- Device master record and bill of materials systems
- Lot and serial number traceability tools
- Production traveller and shop floor systems
- Incoming, in-process and final inspection tools
- Calibration and gauge management trackers
- Nonconformance and corrective action registers
- Complaint handling systems
- Label and unique identification generators
- Sterilisation and outside process trackers
- Installed base and service management systems
- Spare parts and field service tools
- Distributor and tender management systems
- Hospital account and consignment stock tools
- Management dashboards
- Multi-plant device manufacturing platforms
Questions owners ask before starting.
What is custom medical device manufacturing software?
It means a system drawn around your own models, lot records and inspection plans. One job comes first: linking every shipped unit to the lot and serial record behind it, so a hospital’s question about a single device gets a quick answer.
Can it trace a serial number back to its parts?
Yes, if parts are recorded by lot at receipt and issued to a production order. Without that step no system can rebuild the link.
Does it meet a device quality standard?
Not by itself. We do not claim a standard on behalf of the software. Your quality system sets the procedures, and the build follows them.
We outsource sterilisation. Can the system handle that?
Yes. Lots sent out, the cycle record returned and the release decision are recorded, and a lot cannot ship while the record is missing.
Can complaints and service sit in the same system?
Yes. A complaint opens against a serial number and shows its history, and a service visit adds to the same record.
Can it handle both manufacturing and trading?
Yes. Many makers also resell accessories or bought-out items, and these can use simple stock records beside the traced items.
Will it work for a small instrument workshop?
Yes. A smaller shop can start with lot traceability and inspection and add the rest later.
What happens to existing records?
Part lists, customer lists, installed units and open orders are carried across. Older paper records are linked by scan where you want them.
How we work with this trade.
Ready products for this work.
If one of these fits, it is cheaper and faster than building from scratch. We will say so.
Build a device system that can name every unit.
When a hospital rings about one unit, the answer should be quick to find. Parts, process, inspection and shipment should read as one page.
Send one model’s drawing, traveller and inspection sheet. The written reply covers how a single serial number would run through the system.
Tell us how your medical device and equipment manufacturers runs today.
We will tell you what can be digitised, what can be connected, what is worth automating, and what you should leave alone.
What happens after you share your requirements
- A senior engineer reads your answers. Nobody phones first.
- Within one business day you get a written note: what we understood, what we would start with, and the questions we still have.
- If it fits, a proposal follows with the order of work, what we need from you and what you receive at each step.
- No call is booked and nothing is paid until you have read the note. Your details stay with us.
Start with your requirements
Seven short steps that tell us what you need. A senior engineer reads them before anyone gets in touch.
Share your requirements