Established manufacturer
An established manufacturer adding a device to the range, or moving an existing one into Indian production. Enter at Co-Design & Develop for a new product, or at Co-Manufacturing if the design is already fixed.
- Where it ends
- Co-Manufacturing at scale.
Will design and production sit under one quality system?
Yes. One ISO 13485 system covers design, development and manufacturing at both sites, and the same team that designs the device transfers it to production and supports the dossier.
Is this you?
You run an established device company and need extra design capacity, a manufacturing partner, or both.
An established product line
A company with devices on the market, its own quality system and a pipeline of new products.
You need capacity or a site
Engineering for a new device, or a partner to build a device you have already designed.
You worry about control
Quality, records and responsibilities split across two companies, and a regulator who will ask who did what.
Where industry programmes go wrong
- 01
A design file not ready to move
Drawings not released, specifications missing or tests out of date. Production cannot start from a file that only the original team understands.
- 02
Moving sites without the licence
A manufacturing licence under the Medical Devices Rules, 2017 names the manufacturer and the site. A move of production needs regulatory action before units ship from the new site.
- 03
No quality agreement
Two companies that never write down who approves changes, who handles complaints and who holds which records find out during an audit.
What to have ready, and what you leave with
Have ready
- The product requirements, or the released design file
- Your quality system procedures that the work must follow
- Volumes, markets and the licences you hold today
- The supplier qualification steps you will run
You leave with
- Design and verification records that fit your design history file
- A transferred, documented production process
- Batches made with batch records and traceability
- Production that scales with demand
- Post-market support for the device in the field
Design transfer is a stage, not a handover
Design transfer turns the released design into a process that makes the same device every time: work instructions, fixtures, an inspection plan and validated processes. ISO 13485 treats it as part of design and development. Plan it as a stage with its own reviews, because gaps found here are cheaper than gaps found on the production line.
Your path from here
- Step 1
Add engineering where you need it
Design and development work, scoped to the gaps in your team.
Co-Design & Develop - Step 2
Verify against your requirements
Tests and records that fit your design history file.
Verification & validation - Step 3
Transfer the design
Process, fixtures and inspection plan, documented and reviewed.
Design transfer - Step 4
Prove the process in pilot batches
Units built to production records before volume.
Pilot & small-batch - Step 5
Scale production
Larger-scale assembly as demand grows.
Larger-scale assembly - Step 6
Support it in the field
Complaints, service and changes after launch.
Post-market support - Where it ends
Co-Manufacturing at scale
Questions manufacturers ask
Who owns the design and the IP?
Ownership of the design, the IP and the product is agreed in writing before work starts.
Can you build a device we designed?
Yes, through design transfer, which checks the design file and turns it into a documented production process.
Can we audit you?
ISO 13485 asks you to control your suppliers, and an audit is a common way to do it. Plan one into supplier qualification. Our quality system describes our certification.
How are quality responsibilities split?
In a written quality agreement, before production starts: who approves changes, who handles complaints, and who keeps which records.
Design and production in Navi Mumbai
Our design office, labs and audited assembly lines are in Navi Mumbai, across 2 ISO 13485 certified sites. We have designed and developed 40+ devices.
Devices we have worked on
We name the type of device, not the client. Client work stays confidential. See every device type.
- Pulsed lavage irrigation system for orthopaedic surgery
- Battery-powered bone drill with its docking station
- Oscillating-blade dermatome for skin grafts
- Continuous glucose monitoring sensor
Run under an ISO 13485:2016 quality system certified by TÜV SÜD, certificate 99 400 00046. What it covers.
Not quite you?
Three free tools that run in your browser and send us nothing: a readiness check, an intended use builder and your likely class and licence.