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Pilot & small-batch

Enough real units for a clinical evaluation, a regulatory batch or a first sale, built to production records without committing to hard tooling.

Plan your batchTalk to us

When a pilot batch is the right step

Between a working prototype and full production. Batches of 10 to 500 units, built to production records without committing to hard tooling.

  • Test and submit

    Units for lab testing, sterilisation and packaging validation, and the samples a regulatory submission needs.

  • Evaluate in the clinic

    Units for a clinical investigation or a user evaluation. In India, a clinical investigation of a device needs permission under the Medical Devices Rules, 2017.

  • Sell your first units

    A first commercial batch. Devices sold in India must be made under a manufacturing licence that covers the device.

What you bring, and what you get back

You bring

  • Released drawings and specifications
  • A bill of materials, with the parts and suppliers you use today
  • The risk file and the verification results so far
  • Label and instructions-for-use content
  • If something is missing, the design review before the build finds it.

You get back

  • The units, labelled and packed as specified
  • A batch record for each batch, with every step signed off
  • Incoming, in-process and final inspection records
  • Traceability from each unit to its component lots
  • Records of any nonconformance or deviation, and how it was handled
  • What the run taught: the problems found and what to fix before scale-up

Bridge tooling now, production tooling later

FEWER UNITSMORE UNITSPrototype parts3D printingCNC machiningHand fittingPilot batchCast urethaneSoft or aluminium mouldsFixtures and jigsFull productionHardened steel mouldsAutomated linesValidated processesThis serviceTooling you commit to once the design is proven

A pilot batch uses tooling that is quick to make and cheap to change, so the design can still move after the batch shows what needs fixing. Hardened steel tooling is a large commitment, and it pays back only once the design is proven. If a pilot part comes from a bridge process, record why it is equivalent to the production part before its test results count.

How a pilot run works

  1. Step 1

    Review the design file

    We check the drawings, parts list, risk file and test status, and list any gaps.

  2. Step 2

    Plan the build

    Process flow, work instructions, fixtures, the inspection plan and the batch size.

  3. Step 3

    Source and inspect parts

    Components are bought or made, then inspected before they enter the build.

  4. Step 4

    Build and inspect

    Assembly by hand or semi-automatically, with checks during the build and at the end.

  5. Step 5

    Release with records

    Units are released against the batch record, labelled and packed.

  6. Step 6

    Learn before scale-up

    Yield, defects and process issues feed the changes for larger-scale production.

Plan your batch

Add the units each purpose needs. The planner runs in your browser; nothing is sent until you choose to.

Batch size0

Send this plan to us

Opens the enquiry form with your plan filled in.

Questions buyers ask

Can I sell the units from a pilot batch?

Only when the device is licensed for sale in that market. In India, a device sold commercially must be made under a manufacturing licence that covers it. Units for testing or a clinical investigation need their own permissions. India regulatory dossier explains the route.

Can the units be supplied sterile?

Yes, when the sterilisation method and the sterile barrier packaging are validated for the device. Sterile & assembly support covers that work.

Do test results from pilot units count?

They count when the pilot units are made the way production will make them. If a part comes from a bridge process, such as a soft mould, record why it is equivalent to the production part, or repeat the affected tests on production parts later.

How many units should I build?

Count them from your test plan, your clinical protocol and your sales plan, then add spares for failures and rework. The batch planner on this page adds it up for you.

What if my design is not frozen yet?

Then a pilot batch is early. Design transfer fixes and documents the design so that a batch built from it means something.

An assembly bench with tools and parts trays

Built where we design

Pilot batches are built in our own assembly area in Navi Mumbai, next to the design office and labs, so a problem found on the bench goes straight to the engineers who designed the part.

Our quality system · About us

Devices we have worked on

We name the type of device, not the client. Client work stays confidential. See every device type.

Run under an ISO 13485:2016 quality system certified by TÜV SÜD, certificate 99 400 00046. What it covers.

Not quite you?

Standards this work is done against

  • ISO 13485, 7.5Production and service provision

The list for a given device, and the edition of each, is set in its regulatory plan.

Where this sits

  1. 01Co-Innovate
  2. 02Co-Design & Develop
  3. 03Co-Manufacturing
  4. 04Co-Commercialize
  5. +Co-Invest

Also in Co-Manufacturing

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