OE NYT

Helping clients comply with EU requirements in MDR, IVDR, and US FDA Software Guidance for pre-market submissions.

What we do

At OE NYT, our mission is to empower your software team by guiding them through the complexities of quality and regulatory landscapes. We specialize in interpreting and translating intricate industry standards and regulations into actionable strategies that drive innovation and compliance. Our expertise lies in bridging the gap between theoretical knowledge and practical application, enabling your team to navigate the ever-evolving landscape of software quality assurance and regulatory compliance with confidence and precision. By partnering with OE NYT, you gain access to a wealth of experience and a commitment to excellence, ensuring that your software solutions not only meet but exceed industry expectations.

Approach

• Iterative Development: Build design controls and documentation step-by-step, ensuring clarity and alignment with regulatory standards.
• Early Compliance: Integrate compliance considerations early in the project lifecycle, reducing risks and streamlining the path to certification.
• Focus on Innovation: Enable your team to concentrate on innovative solutions, confident in the robustness of quality and compliance measures.