Sardhara Medical - Innovating at the edge of life

Company

Engineering at the edge of life

An India-based medical technology company developing the extracorporeal and critical-care systems that support life at its most fragile moments.

Who we are

Sardhara Medical is an India-based medical technology company focused on the engineering of extracorporeal and critical-care systems - the technologies that support life at its most fragile moments.

We bring together design-controlled engineering, close clinical collaboration and disciplined manufacturing to develop advanced devices with the ambition to serve critical care everywhere.

Headquarters
Vadodara, Gujarat, India
Focus
Extracorporeal & critical care
Approach
Design-controlled engineering
Ambition
Built in India, engineered for the world

Leadership

Board of Directors

Sardhara Medical Private Limited is led by its Founding Directors, who set the strategy, governance and quality culture that guide every function of the company.

Portrait of Dr. Vishal Sardhara

Dr. Vishal Sardhara

Managing Director

Founding Director & Board Member

Dr. Vishal Sardhara is a Founding Director of Sardhara Medical Private Limited and serves as its Managing Director. A critical-care physician by training, he leads the company’s clinical and engineering vision, ensuring that every extracorporeal and critical-care system is grounded in real frontline patient need.

His perspective is deeply personal: during the COVID-19 pandemic he was himself sustained on ECMO and is an ECMO survivor. Having experienced critical care from both sides of the bed, he is committed to building a quality-first organisation - one where design controls, risk management and clinical insight guide the development of devices that clinicians can trust at the most fragile moments of care.

Portrait of Mr. Vivek R. Sardhara

Mr. Vivek R. Sardhara

Director

Founding Director & Board Member

Mr. Vivek R. Sardhara is a Founding Director of Sardhara Medical Private Limited. He drives the company’s operations, manufacturing strategy and commercial growth, translating engineering ambition into repeatable, quality-controlled production.

He is committed to establishing scalable, traceable processes and enduring relationships with clinicians, partners and institutions across India and beyond.

A message from our Managing Director

As a critical-care physician, I spent years standing beside patients at the very edge of life - watching extracorporeal support do what nothing else could, and knowing how much every tube, pump and circuit truly matters. During the COVID-19 pandemic, I crossed to the other side of that machine. I became the patient. My own life was sustained on ECMO, and I am here today as an ECMO survivor.

That experience changed everything. I have felt, in my own body, the fragile margin between life and loss that these technologies hold open. I know what it means for a family to wait while a machine breathes for someone they love. Sardhara Medical was born from that understanding - from a conviction that the systems supporting life at its most fragile moments deserve uncompromising engineering, rigorous quality and genuine clinical empathy.

As Founding Directors, my brother Mr. Vivek R. Sardhara and I set out to build more than a company - we set out to build a quality culture. Every decision we make, from the first line of a design input to the final inspection of a device, is weighed against a single question: is this safe and effective for the patient and the clinician who depends on it? For me, that patient is never abstract. I have been that patient.

We are proud to be building this from India, and we are building it to serve the world. Our commitment is to develop extracorporeal and critical-care systems that meet the highest international standards, and to earn the trust of every clinician and institution we work with - so that more patients are given the second chance I was fortunate to receive.

On behalf of the Board, thank you for your interest in Sardhara Medical. We look forward to building the future of critical care together.

Dr. Vishal SardharaManaging Director

Organisation

How we are organised

Sardhara Medical is structured around the functions that carry a critical-care device from first concept to controlled manufacture - each accountable, and each connected through a shared quality culture.

Governance

Board & Leadership

Sets strategy, governance and the quality culture that guides every function across Sardhara Medical.

01

Engineering & Product Development

Owns concept-to-design of extracorporeal and critical-care systems under a design-controlled process.

02

Quality Assurance & Regulatory Affairs

Maintains the quality management system, risk files and the regulatory strategy as products mature.

03

Manufacturing & Operations

Develops repeatable, controlled production and supply processes built for consistency and traceability.

04

Clinical Affairs

Coordinates clinical collaboration so engineering decisions stay grounded in frontline critical care.

05

Commercial & Customer Support

Builds relationships with clinicians and institutions and supports them through the product lifecycle.

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.

In progress

ISO 13485

Medical device quality management systems

Design aligned

ISO 14971

Application of risk management to medical devices

Design aligned

IEC 60601

Safety of electrical medical equipment

Planned

ISO 10993

Biological evaluation of medical devices

In progress

CDSCO (India)

National medical device regulatory pathway

Planned

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.

Get in touch

Let's build the future of critical care together

Reach our team at contact@sardharamedical.com or +91 96878 22229.