Quality
Our quality system is certified to ISO 13485 by TÜV SÜD, valid from 2025 to 2028. The certificate and its scope statement are available on request.
- What the certificate covers
- The certified scope is the design and manufacture of medical devices, at both sites. It certifies the system and not any one device: every device is still assessed on its own, against the standards that apply to it and the route to market you are taking.
- Standards we work to
- The standards a programme here is run against, chosen by what the device is: ISO 14971 for risk on every programme, IEC 62366-1 for usability, IEC 62304 where there is software, ISO 10993 where a material touches the patient, and IEC 60601-1 with IEC 60601-1-2 for powered equipment.
The certificate
- StandardISO 13485:2016, medical devices quality management systems
- Certification bodyTÜV SÜD South Asia
- Certificate99 400 00046
- First certified25 August 2025
- Valid until24 August 2028, subject to annual surveillance audits
- ScopeDesign, development and manufacturing of medical devices including screening, diagnostic, surgical, monitoring, assistive, rehabilitation and therapy devices
Certified sites
Design, development and manufacturing
Office No: 1101/02/03/04, 11th Floor, KAMDHENU 23 WEST, Plot No. A-10/2 & A-11, Thane-Belapur Road, Kopar Khairane, Navi Mumbai 400709
Certificate 99 400 00046/01 · Map
Manufacturing
3rd Floor, Plot A-22, TTC Industrial Area, Khairane, Navi Mumbai 400705
Certificate 99 400 00046/02 · Map
How the system runs
Clause 7.3
Design controls
Planning, inputs, outputs, reviews, verification, validation, transfer and change control, recorded as the work goes.
ISO 14971
Risk management
Hazards identified, risks controlled and the controls checked, from concept to the field.
Clause 7.4
Suppliers
Suppliers evaluated and approved, and what they deliver checked.
Clause 7.5
Production and traceability
Work instructions, batch records and traceability for every unit.
Clauses 8.2 and 8.5
Complaints and CAPA
Complaints handled, causes found and corrective actions checked for effect.
Clauses 8.2.4 and 5.6
Audits and review
Internal audits and management review of the system itself.
What our certification means for your device
A design file you can submit
Design controls run as the work goes, so the design history file is ready for your dossier, not rebuilt at the end.
Traceable production
Work instructions, batch records and traceability for every unit, from the first build.
Suppliers under control
Suppliers are evaluated and approved, and what they deliver is checked before it is used.
The certificate covers the system, not your device
ISO 13485 certifies how we design and make devices. Each device is still assessed on its own, against the standards that apply to it, and approved by the regulator of each market you sell in.
Questions about our quality system
Does your certificate certify my device?
No. It certifies our quality system for the design, development and manufacture of medical devices. Your device needs its own evidence and its own approval in each market.
How is the certificate kept valid?
By surveillance audits every year, and it runs until 24 August 2028.
Can I see the certificate?
Yes. The certificate and its scope statement are available on request. Ask us.
Is ISO 13485 enough for a licence in India?
The Medical Devices Rules, 2017 set their own quality system requirements, and they follow ISO 13485 closely. The licensing authority still assesses each manufacturing site and each device.
Audited every year
Our system is certified by TÜV SÜD at both sites, and each year a surveillance audit checks that it still runs the way the certificate says.
Need the certificate or its scope statement?
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