Quality & Compliance
Quality is engineered in, not inspected on
Our quality management system is built in alignment with the international standards that govern medical devices - designed to protect the patients and clinicians who depend on our technology.
Quality Policy
Our commitment to quality
A statement of the principles that guide how we design, build and improve our devices.
Sardhara Medical is committed to designing, developing and manufacturing extracorporeal and critical-care devices that are safe, effective and consistently meet the needs of the clinicians and patients who depend on them.
We operate a quality management system built in alignment with ISO 13485 and applicable regulatory requirements, and we are committed to the continual improvement of its effectiveness across every function of our business.
Patient safety first
Every design decision is weighed against its impact on the safety of the patient and the clinician using the device.
Regulatory compliance
We work to meet the requirements of the markets we intend to serve, beginning with India (CDSCO) and building toward international access.
Risk-based thinking
Risk management under ISO 14971 principles runs through the entire product lifecycle, from concept to post-market.
Continual improvement
We measure, review and improve our processes so that quality strengthens as the organisation grows.
Competence & training
People performing work that affects quality are trained, qualified and supported to do it well.
Supplier quality
We select and evaluate suppliers against defined criteria so that quality is built into the supply chain.
Accreditations & Standards
The standards we build around
Our quality management and engineering processes are designed in alignment with the international standards that govern medical devices. As our systems progress through development, we are working toward formal certification and regulatory clearance.
ISO 13485
Medical device quality management systems
ISO 14971
Application of risk management to medical devices
IEC 60601
Safety of electrical medical equipment
ISO 10993
Biological evaluation of medical devices
CDSCO (India)
National medical device regulatory pathway
CE / EU MDR
European conformity for future market access
Regulatory status
Sardhara Medical products are currently in development. The standards above describe the frameworks our quality and engineering processes are built around and are working toward - they are not statements of current certification, and no product listed on this site is certified or approved for sale.
Regulatory Approach
How compliance is built into development
Our regulatory strategy is embedded in the engineering process, not bolted on at the end.
Design controls & Design History File
Requirements, design inputs and outputs, reviews and verification are documented with full traceability from the outset.
Risk management file
Hazard analysis, risk evaluation and mitigation are maintained as living documents throughout development.
Verification & validation
Structured V&V confirms that devices meet defined requirements and perform as intended before release.
Post-market surveillance & vigilance
A defined channel for complaints and adverse-event reporting feeds directly back into our quality system.
Registrations & Certificates
Company & regulatory details
Our formal registrations and certifications as they are granted. Items marked in progress are being pursued as our devices mature toward market.
- Legal entity
- Sardhara Medical Private Limited
- Corporate Identity Number (CIN)
- U32509GJ2026PTC184082
- Certificate of Incorporation
- Incorporated 23 September 2026 · Registrar of Companies, Central Registration Centre
- Registered office
- Tower-A, 4th Floor, Silver Square, B/s Patel Timber, Harni Colony, Vadodara - 390022, Gujarat, India
- GSTIN
- 24ABVCS1474P1ZG (Gujarat)
- Importer-Exporter Code (IEC)
- ABVCS1474P · Issued 21 October 2026 · DGFT, Vadodara
- Udyam (MSME) Registration
- UDYAM-GJ-24-0255966 · Micro enterprise, Manufacturing (NIC 32503)
- CDSCO Manufacturing Licence
- [Licence number - application in progress]
- ISO 13485:2016 Certificate
- [Certificate number - certification in progress]
- CE / EU MDR
- [Planned for future international market access]
Sardhara Medical products are currently in development. Certification and licence numbers are shown here as they are formally granted and are not statements of current approval to market. For verified regulatory documentation, please contact contact@sardharamedical.com.
Report a product complaint or adverse event
If you have experienced or witnessed a safety issue involving one of our devices, please tell us. Every report feeds directly into our vigilance and post-market surveillance process.
Partner with us
Talk to our quality & regulatory team
Reach us at contact@sardharamedical.com or +91 96878 22229.