The standards we build our processes around.
We are setting up our quality management system in line with these international standards from day one, and will pursue formal certification as our operations scale.
Quality management
Quality management systems — the foundation for documented, repeatable processes across design, printing and delivery.
Additive manufacturing terminology, so customers, partners and our team describe processes and materials the same way.
Requirements for purchased AM parts — clear specifications, acceptance criteria and documentation for every order.
Qualification principles for industrial additive manufacturing processes and sites.
Medical devices
Quality management systems for medical devices — design controls, traceability, supplier control and records.
Risk management for medical devices — identifying, evaluating and controlling risks across the product life cycle.
Biological evaluation of medical devices — biocompatibility of materials that touch the skin or body.
Requirements and structural testing for external limb prostheses and orthoses.
Aerospace & automotive
Quality management for aviation, space and defence — the route for flight and mission components through qualified partners.
Automotive quality management — the expectation for series automotive and EV supply.
How we work on medical products.
Healthcare products affect people's bodies and lives. These principles apply to every orthotic, prosthetic, dental and medical project we take on.
Prescription-led
Patient-specific orthotic, prosthetic and medical products are made only on the prescription or request of a qualified, registered healthcare professional.
Clinician in the loop
Design decisions for medical products are reviewed and approved by the treating clinician before production and before patient use.
Informed consent & privacy
Patient scans and data are used only with consent, for the stated purpose, and are protected under India's DPDP Act, 2023.
Validated materials
Only materials with suitable biocompatibility data for the intended contact and duration are used for body-contact products.
Traceability
Each medical part is linked to its design file, material batch, machine, process settings and inspection record.
Regulatory compliance
Products classed as medical devices follow India's Medical Devices Rules, 2017 under CDSCO, including licensing and labelling, before they are supplied.
Post-delivery follow-up
Fit checks, feedback and complaint handling are recorded so that issues are investigated and corrected.
Clear limits
Implants and other high-risk devices are part of our long-term roadmap and will be offered only after the required certification, testing and approvals.