One connected system for device records, production lots, inspections and complaints.
Manage device bills of materials, production orders, component lots, serial numbers, inspections, supplier approvals, complaints and shipments in one system. Each finished lot carries the parts that went into it, the checks it passed and the customers who received it. Quality teams open one record to trace a device forwards or backwards. Production sees the same plan.
- Device families, component lists and inspection plans entered the way your quality system defines them
- Part masters, supplier lists and open orders migrated
- Changes to routings, forms and approval steps made by GullySystem staff when asked
Medical Device Manufacturer Management Software holds bills of materials, production orders, lot records, inspections and complaints for makers of devices and consumables. GullySystem configures it for your plant. Every finished lot links to its component lots, its inspection results and its shipments. Corrective actions stay beside the complaint that raised them. Document rules and approval steps follow your own quality system.
What goes wrong before the software.
How the work flows through it, step by step.
- 1
Enquiry and quotation
A hospital, distributor or brand owner asks for a device or a contract run. Your device price list and its quantity breaks feed straight into each quotation, and the specification revision is noted on it.
- 2
Order and production plan
A confirmed order becomes a production order against the current bill of materials revision. Planners see which components, moulds and machines are needed. The routing starts from the first operation.
- 3
Receiving and approved parts
Components arrive from approved suppliers and are held in quarantine until incoming inspection is signed, so nothing reaches the cleanroom early. Each receipt creates a component lot. Gowning and area logs link to it.
- 4
Production and inspection
Operators record each step against the lot, including cavity, extrusion line or autoclave cycle. In-process and final checks follow the inspection plan, and a failed check blocks release until the quality team decides on rework or scrap.
- 5
Release and shipment
A released lot is packed and shipped with its serial numbers or lot number, and the customer, the lot and the invoice are linked. Dispatch is one step. The device history record closes complete.
- 6
Feedback and corrective action
Complaints and returns are logged against the lot. Investigations, corrective actions, preventive actions and approvals are recorded until closure, and a trend by device and cause is available to the quality review.
What is inside.
Every module can be switched on, left out or changed to match how your team already works.
The business modules it is built from.
Each one is also available on its own, or inside a system built for you.
- Bill of Materials
Each device is stored as a revisioned list of components and quantities, so planners release production against the current build and not an older printout.
- Work Order Management
Every lot gets a production order with its routing, machine and operator, and each step is recorded as the cell finishes it.
- Batch and Serial Tracking
Component lots, finished lots and serial numbers are linked, so one search follows a device to its customers or back to its parts.
- Quality Control
Inspection plans for parts and devices hold measurements and pass or fail results, and a failed check keeps the lot from release.
- Ticket Management
A complaint becomes a numbered record tied to its lot, with an owner, an investigation, a corrective action and a closing approval.
- Document Management
Procedures, work instructions and specifications are stored with revision numbers and approval dates, so staff on the floor open the current copy.
- Job Work Management
Parts leave on a dispatch note for an outside processor, and the return, its certificate and the lot it covers are recorded together.
- Vendor Management
Approved supplier status, audit dates and certificates sit on each supplier, and purchasing sees the status before an order is raised.
How we would put it in.
Setup, data migration, integrations and anything built on top.
One system, each person sees their part.
For owners and plant heads
See lots in production, orders due, open complaints, supplier reviews and stock value on one screen. Nothing is hidden. Every figure opens the records behind it, down to the individual lot.
For quality and regulatory teams
Run inspections, review complaints, approve documents and pull a trace report for any lot. Open corrective actions and overdue supplier audits are listed first, ahead of everything else.
For production planners
Plan orders against components, moulds and machines, and release production orders with the right revision. Shortages are flagged before release. No order starts without parts.
For operators and technicians
See assigned production orders, record steps and measurements, and flag a problem from a shop floor screen. Work instructions open at the step being done, with the gauge and limit shown.
For purchasing and stores
Raise orders to approved suppliers, receive goods, hold them in quarantine and issue approved lots to production. Expiry dates and reorder levels show on the stock screen.
The numbers the owner asks for.
- Lot trace from finished device to component lots and shipments
- Production orders by status, machine and due date
- Inspection results and failures by part and supplier
- Complaints by device, cause and closure status
- Corrective actions open, overdue and closed
- Supplier approval status and certificate expiry
- Stock of components and finished goods by location
Who this is built for.
- Makers of single-use and disposable devices such as syringes, catheters and dressings
- Manufacturers of diagnostic kits, monitoring devices and electronic medical equipment
- Contract manufacturers that build devices under another company’s brand
- Producers of orthopaedic, dental and surgical instruments in small and mid-sized plants
- Device makers that sell through distributors and direct to hospitals
When it is not the right choice.
- A distributor that only buys and resells finished devices needs stock and invoicing more than production records.
- A hospital or clinic that only uses devices, not makes them, is better served by Hospital Operations Management Software.
Adapted to your business before it goes live.
You are not handed a login and left to it. The product is set up around your records, your people and the tools you already use.
Works alongside
- SMS
- WhatsApp and other messaging
- Barcode and label printers
- Accounting software export
- Spreadsheet import
Questions owners ask before a demo.
Does it follow one particular quality standard?
It is a record system, not a certificate. Forms, approval steps and document rules are set to your own quality system, and the fit with your regulator’s expectations is reviewed during implementation.
Can a device be traced back to its component lots?
Yes. Each finished lot links to the component lots consumed and to the customers shipped to. The trace works in both directions from one search, which helps when a supplier reports a bad resin lot.
Can it handle serial numbers as well as lot numbers?
Yes. Some devices are tracked by serial number and others by lot. The choice is made for each part, and labels print with the fields you set, including barcodes your customers scan.
How are complaints linked to corrective actions?
A complaint is logged against a lot. The investigation and any corrective action stay on that one record, each with an owner and a due date, until an approver signs it off.
What happens when a bill of materials changes?
A new revision is created with an effective date. Production orders released after that date use it. Orders already open keep the revision they started with, so one lot is never built on mixed documents.
Can parts sent for sterilisation or coating be followed?
Yes. A job-work dispatch note records what left, who holds it and when it is due back. The returning sterilisation or coating certificate is attached to the lot it covers.
Can we bring in our existing part and supplier lists?
Yes. Part masters, bills of materials, supplier lists and open orders are imported from spreadsheets, and your quality team verifies a sample of lots before production moves over.
Do operators need a computer at each machine?
A tablet or a shared screen at each cell is enough. Operators pick an order, record steps and measurements, and flag a problem, scanning the barcode on the lot being built.
Who owns our production records?
You do. The format and route by which your lot records are handed back are written into the quotation, ahead of any build work.
How is pricing worked out?
The proposal reflects how many users, how many plants and how many controlled document types you need. Before any figure is quoted, we demonstrate the system on your own part list. Then the proposal arrives in writing.
Wondering what it costs? Six questions give you a written scope and the buckets any quote should separate.
Businesses that use this.
See Medical Device Manufacturer Management Software with your own data.
Tell us how you run things today. We’ll show you the parts that matter to you and say plainly what would need changing.
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- A reply within one business day
- Your details stay private
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