Stefanini’s Medical Device Software Development Services deliver innovative, regulatory-compliant software solutions to drive the future of healthcare.

In today’s digital healthcare landscape, software is transforming medical devices and driving the next wave of healthcare innovation. At Stefanini, we specialize in the development of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), providing end-to-end support for organizations seeking to bring safe, compliant, and user-friendly medical device software to market.

Our expert team ensures your software is developed to meet the highest industry standards, with regulatory compliance at the forefront of our solutions. Whether you’re a startup or an established organization, we provide the expertise to navigate complex regulations and ensure the timely, cost-effective delivery of your product. From the initial concept to post-market updates, Stefanini is your partner in building compliant, innovative healthcare solutions.

What You’ll Find in the Brochure:

• Full Lifecycle Software Development
  • Regulatory Compliant Software Design
  • Risk Management & Cybersecurity Solutions
  • Verification & Validation Services
  • User Interface and User Experience Optimization
  • Post-Market Support and Updates

Why Choose Stefanini?

✔ Innovation with Safety:
We blend cutting-edge technology with rigorous safety standards to deliver software that is both innovative and compliant.
✔ Unmatched Expertise:
With over 50 years of combined experience, we offer deep technical expertise and regulatory insights to guide your product to market.
✔ Compliance-First Approach:
From FDA to EU MDR compliance, we ensure your software meets the highest regulatory standards for safety and efficacy.
✔ Comprehensive Lifecycle Support:
Stefanini provides tailored services for every stage of the product lifecycle, from planning and development to launch and post-launch maintenance.
✔ Tailored Solutions:
Whether you’re a startup or an enterprise, we craft customized solutions that address your unique business needs and regulatory challenges.

Is Your Medical Device Software Ready for Market?

Are you confident that your medical device software meets regulatory standards and is prepared for a smooth market launch? Stefanini’s expertise in SaMD and SiMD development ensures your product not only meets compliance requirements but sets new standards for innovation, safety, and usability.

Let’s build the future of healthcare together.