Our Expertise
Diabetes Management
Cardiac Care
Oncology Solutions
Wearables
Ensuring Compliance with Industry Standards
01. 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.
02. 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.
03. 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.
04. 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.
05. 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.
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