Our Expertise

We offer comprehensive capabilities that enable faster, safer, and more efficient development of medical technologies. From end-to-end product development to infrastructure, talent, and operational models, we provide the complete ecosystem required to bring innovative MedTech solutions to life.

End-to-End Product Development

We support the complete development journey of a medical product, from early concept and feasibility through engineering, prototyping, testing, and regulatory preparation.

Our end-to-end capability includes:

  • Requirement definition and concept exploration

  • System, hardware, software, and mechanical engineering

  • UI/UX design aligned with clinical workflows and usability requirements

  • Prototype development and iterative improvement

  • Verification, validation, and compliance documentation

  • Support toward manufacturing readiness

 

Proven Leadership

Our leadership team brings broad experience in medical devices, digital health, embedded systems, and regulated engineering environments. We guide projects with a strong focus on quality, compliance, and innovation.

Our leadership strengths include:

  • Extensive experience in managing offshore development teams and Global Capability Centers

  • Deep understanding of MedTech standards and development workflows

  • Experience collaborating with startups, clinicians, and industry partners

  • Strong technical oversight across system, software, hardware, and mechanical teams

  • Commitment to delivering safe, reliable, and high-quality medical solutions

Expert Engineering Team

We offer specialized engineering talent across all major disciplines needed for medical product development. Our team combines technical expertise with an understanding of medical standards and workflows.

Our Technical Strength includes:

  • System Architects
  • Hardware engineers
  • Mechanical designers
  • Software and AI/ML engineers
  • UI/UX designers
  • V&V  engineers
  • Quality and regulatory specialists

Ecosystem Support

We collaborate with trusted partners and fabrication networks to provide an extended ecosystem that supports rapid development and iteration of medical technologies.We ensure seamless access at the right time through our partner ecosystem.

Our ecosystem capabilities include:

  • Rapid prototyping through partner facilities for Medtech products
  • Access to testing and debugging environments required for early-stage validation
  • Strong relationships with fabrication and manufacturing partners for quick turnaround builds
  • Collaboration with universities and academic institutions to support  research & innovation

Ensuring Compliance with Industry Standards

ISO 13485

This standard sets out the requirements for a quality management system specific to the medical device industry. By complying with ISO 13485, we demonstrate our dedication to consistently meeting customer and regulatory requirements.

ISO 14971

Risk management is a critical aspect of medical device development, and ISO 14971 provides a framework for identifying, assessing, and mitigating risks throughout the product lifecycle. We follow this standard rigorously to ensure that potential risks are identified and addressed proactively.

IEC 60601-1 Series

The IEC 60601-1 series of standards covers the safety and essential performance of medical electrical equipment. Our expertise in this series ensures that our devices meet the necessary safety requirements, protecting both patients and healthcare professionals.

IEC 62304

Software plays a significant role in modern medical devices, and IEC 62304 provides guidance on software lifecycle processes. We adhere to this standard to ensure the reliability, safety, and effectiveness of software used in our medical devices.

IEC 62366

This standard focuses on usability engineering for medical devices, emphasizing the importance of designing devices that are intuitive, safe, and easy to use. Our adherence to IEC 62366 ensures that our devices meet user needs and contribute to better patient outcomes.

Get in Touch

Ready to experience the difference? Contact us today to learn how we can support your medical device development needs.