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 DevelopmentTailored medical software solutions that ensure compliance and reliability
- Prototyping & DesignEfficient prototyping and design processes to meet your unique requirements
- Regulatory ComplianceExpertise in ISO 13485, MDR, and FDA to navigate the regulatory landscape
- Technical DocumentationHigh-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