In the realm of Software as a Medical Device (SaMD), Stark Pharma brings specialized capabilities in compliant software engineering and digital health innovation. Our software development life cycle aligns with IEC 62304 standards and integrates seamlessly with your device’s regulatory and clinical pathways.
Aligned with IEC 62304:2006, ensuring software lifecycle management meets global safety and quality expectations.
Creating modular, robust, and scalable frameworks that are easy to validate and maintain.
Conducting comprehensive unit, integration, system, and acceptance testing to ensure software performance and reliability.
Developing intuitive, patient- and clinician-friendly interfaces that enhance usability and reduce errors.
Building interoperable apps with IoT capabilities, secure data storage, and compliance with HIPAA and GDPR standards.
We combine biomedical engineering, software development, and regulatory knowledge under one roof—ensuring alignment from user needs to final submission.
Our quality systems and design practices meet key regulatory standards for both hardware devices and SaMD.
Whether you're developing a handheld device or a cloud-connected digital health platform, we offer scalable design services to support your vision from pilot to production.
+1 (732)760-5152
hr@starkpharma.com
