Developer for Software as a Medical Device (SaMD)
Medical Device Software Development
Looking for a trusted partner in medical device development? We specialize in delivering compliant and innovative medical devices that meet global standards, including ISO 13485, IEC 62304, EU MDR 2017/745, and FDA regulations. From initial concept to final product with complete technical documentation, we support the entire development lifecycle.
Key Services We Offer:
Software Development
Tailored medical software solutions that ensure compliance and reliability
Prototyping & Design
Efficient prototyping and design processes to meet your unique requirements
Regulatory Compliance
Expertise in ISO 13485, MDR, and FDA to navigate the regulatory landscape
Technical Documentation
High-quality documentation to streamline regulatory approval
Why Choose Us?
Proven track record in medical device development
Expertise in ISO 13485, IEC 62304, and FDA/MDR compliance
Dedicated team for software, quality assurance, risk management, and technical documentation
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