Larger-scale assembly
Volume assembly on our own audited lines in Navi Mumbai, with batch records, traceability and release testing on every build.
When larger-scale assembly is the right step
After a pilot batch has proven the process and the design is stable. Assembly moves onto the assembly lines at our TTC Khairane site.
Move from pilot to volume
Take a process proven in a pilot batch onto lines set up for more units.
Supply a launched product
Repeat batches for a device that is licensed and on the market.
Manufacture in India
Assembly under an ISO 13485 audited quality system in India, for the Indian market or for export where the device is approved.
What you bring, and what you get back
You bring
- The device master record, or released drawings and specifications
- An approved bill of materials, with suppliers
- Results and records from the pilot batch
- A volume forecast
- The regulatory status of the device in each market you sell to
You get back
- Assembled units, labelled and packed as specified
- A batch record for each batch
- Incoming, in-process and final inspection records
- Traceability from each unit to its component lots
- Controls on suppliers and purchased parts
- Records of nonconformances and changes, and how they were handled
Scaling up is a change, not a repeat
A process that worked for a pilot batch may not behave the same way on a faster line, with new tooling or a second supplier. Each of those is a change. Under ISO 13485 a change is assessed for its effect on the device, and a process whose result cannot be fully checked afterwards is validated again. Planning that work early keeps the ramp-up from stalling.
How larger-scale assembly runs
Questions buyers ask
Do I need a pilot batch first?
In most cases, yes. A pilot batch shows where the process breaks before you commit to production tooling and volume. See Pilot & small-batch.
What licence does commercial production need in India?
A device made for sale in India needs a manufacturing licence under the Medical Devices Rules, 2017, that covers the device and the site. Agree who holds it before the first commercial batch. India regulatory dossier explains the route.
How are purchased parts controlled?
Suppliers are evaluated before use, and parts are checked on receipt to the level their risk calls for. ISO 13485 sets this out under purchasing controls.
Can units be made for export?
Yes, where the device is approved in the destination market. Each market has its own route. Global regulatory covers them.
Audited manufacturing in India
Assembly runs at our TTC Khairane site under an ISO 13485 audited quality system. We operate 2 ISO 13485 certified sites in Navi Mumbai, with the design office and labs alongside.
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
- ISO 13485, 7.4Purchasing and supplier controls
The list for a given device, and the edition of each, is set in its regulatory plan.
Where this sits
Also in Co-Manufacturing
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