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GullySystem
Manufacturing · Software for medical device manufacturers

Trace every device lot to its parts, its checks and its customers.

A device that reaches a patient carries a long paper trail behind it: which parts went in, who checked it and where it was sent. The medical device manufacturer software holds that device history record as one chain per lot. Inspections, supplier approvals, nonconformances and complaints attach to the same record, and your quality team sets the forms.

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At a glance

Medical device plants make everything from single-use syringes and catheters to electronic patient monitors. The product differs, but the records they must keep look alike: component lots, routing steps, inspection results, UDI labels, sterilisation certificates, shipments and complaints.

Production and quality software for device makers keeps those records joined, so a quality manager can search one lot and see the parts, the checks and the customers together. The system holds the records. Your quality system decides what they must say.

How the work runs today

A hospital group, distributor or brand owner places an order or a contract run, and planners release a production order against the current revision of the bill of materials. Components from approved suppliers must be in stock. Incoming goods wait in quarantine until the inspector signs the receipt. Then the lot goes to the floor.

Operators record each step at the cell, from injection moulding or assembly in the cleanroom to leak testing and pouch sealing, while inspectors take in-process and final measurements against the plan. Parts that need ethylene oxide or gamma sterilisation, or a coating, go to an outside processor and return with a certificate. A released lot is labelled, shipped and invoiced. Nothing ships without a release. When a complaint arrives weeks later, the quality team opens the lot and works back from there.

Where it breaks

What goes wrong for medical device manufacturers without a proper system.

Trace records live in separate files

Goods receipts, production sheets and shipping lists sit in different places, so a trace from one finished device to its resin batch or circuit board means opening each of them. An audit day stretches.

Old revisions stay in circulation

A device master record is updated, but a printed copy of the earlier bill of materials stays at a workstation. Parts are built to the wrong list. Rework follows.

Inspection forms are filed away from the lot

Signed torque, leak and dimensional checks are stored in binders by date, so finding the result for one lot months later takes a search through boxes.

Complaints and actions are tracked apart

A complaint arrives by email, while the investigation and the CAPA are written in other documents. Closure then depends on memory, and the nonconformance report is filed separately.

Supplier approval lapses unnoticed

Audit dates, quality agreements and sterilisation certificates sit with one person, so purchasing can raise an order to a source whose approval has expired. Nobody sees it until the notified body asks.

What the software does

What we would build for medical device manufacturers.

Named the way your team already talks about the work. We start with whichever part the audit shows is costing you most.

Bills of materials and revisions

Hold each device as a revisioned list of components and labels, with an effective date so the floor builds to the current revision. Superseded lists are locked from use.

Production orders and routings

Release an order for each lot with its routing, work cell, tooling and operator, and record each step as it is completed, from moulding through assembly to final pack.

Lot and serial traceability

Link component lots, finished lots, serial numbers, UDI codes and shipments, so a recall trace runs forwards to customers or backwards to the resin and board suppliers from one search.

Inspection and release

Record incoming, in-process and final results against a sampling plan. A failed lot is held in quarantine until a reviewer decides what happens to it, and the decision is signed.

Complaints and corrective actions

Log each complaint against its lot and carry the investigation, the nonconformance report, the CAPA and the closing approval on one record, with due dates and owners.

Supplier approval and outside processing

Keep approved supplier status, audit dates and sterilisation or coating certificates, and send parts out on a delivery note that returns with its processing paperwork and lot numbers.

Before you talk to a supplier

A requirements checklist for medical device manufacturers.

What to cover, which reports to ask for and what to put to every vendor, ready to print or save as a PDF.

Open the checklist
Ready product

A product already built for medical device manufacturers.

It is adapted to how your business works before it goes live, and anything your trade needs that it lacks is added then.

Medical Device Manufacturer Management Software

Bills of materials, production orders, lot and serial records, inspections, supplier approvals, complaints and shipments for medical device manufacturers.

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Solutions inside

The business modules medical device manufacturers use most.

Each one is also available on its own, or inside a system built for you.

Services

The services behind it.

Business Process Automation

Approvals, reminders, follow-ups and reports that run on their own instead of on someone remembering.

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ERP, CRM and Business Software Implementation

One record of stock, orders, customers and accounts, set up so your team opens it every day.

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Data Migration and Moving Off Spreadsheets

Data migration and spreadsheet replacement covers auditing existing files, cleaning and deduplicating records, loading them into a new system and reconciling the result against known totals. A parallel run of both systems comes before cutover. The original files are kept as they were.

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How it works

How the work runs from Bengaluru for your city.

  1. 1

    The audit, by call

    A screen-share and a look at the sheets, Tally reports and WhatsApp groups your team uses. No travel needed.

  2. 2

    A written proposal

    Scope, what we build first and the cost, agreed in writing before anything starts.

  3. 3

    Build in short rounds

    Working screens shared every few weeks. Your team tests them from your own office.

  4. 4

    Go-live, in person when it helps

    For data migration and training we can come to your city. Travel is agreed in advance.

  5. 5

    Support online

    Fixes, changes and hosting handled remotely by the same team that built it.

Our work

Software we have built and run.

We only name clients whose work is published. These are systems our team designed, built and supports.

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Common questions

Questions medical device manufacturers ask before they call.

Does the software make us compliant with a device standard?

No software can do that alone. It holds the records your quality system calls for, such as the device history record and CAPA log. How well the forms match your regulator’s expectations is reviewed during implementation.

Can it manage labels with lot and serial data?

Yes. Label fields and UDI barcodes are set for each device, and the lot, serial number and expiry date printed are the ones held on the production record.

Does a small plant get value from it?

Often, yes. A plant with a few product lines and one quality manager can use the same lot, inspection and complaint records, with fewer approval steps set up and no extra cleanroom paperwork.

Can contract manufacturing runs be kept separate?

Yes. Each customer’s devices, bills of materials and lots can be kept apart, with their own price lists, labels and shipping records.

What happens in the free technology audit?

We look at the software, spreadsheets and WhatsApp groups your business runs on today and write down what works, what slows your team down and what is missing. A demo login, a screen-share or a few screenshots are enough to start. You get a report ordered by priority, and there is no obligation to hire us afterwards.

How much will the software cost?

We don’t publish a price, because it depends on what the system has to do. The audit settles the scope, and the cost goes into a written proposal before any work starts.

Related

Related industries.

Category

Part of a wider group.

Talk to us

Tell us how your business runs today.

A few lines on your spreadsheets, software and WhatsApp groups is enough. We reply the same working day.

  • No obligation
  • A reply within one business day
  • Your details stay private

Start with your requirements

Seven short steps that tell us what you need. An engineer reads them before getting in touch.

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