Software as Medical Device

Designing Compliant, Scalable Software for Regulated Healthcare Applications

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.

Our Core Software as Medical Device Capabilities

Medical Software Development

Aligned with IEC 62304:2006, ensuring software lifecycle management meets global safety and quality expectations.

Software Architecture Design

Creating modular, robust, and scalable frameworks that are easy to validate and maintain.

Verification & Validation (V&V)

Conducting comprehensive unit, integration, system, and acceptance testing to ensure software performance and reliability.

UI/UX Design

Developing intuitive, patient- and clinician-friendly interfaces that enhance usability and reduce errors.

Mobile & Cloud Integration

Building interoperable apps with IoT capabilities, secure data storage, and compliance with HIPAA and GDPR standards.

why ChooseStark Pharma for Software as Medical Device?

Cross-Functional Expertise

We combine biomedical engineering, software development, and regulatory knowledge under one roof—ensuring alignment from user needs to final submission.

ISO 13485 & IEC 62304 Compliance

Our quality systems and design practices meet key regulatory standards for both hardware devices and SaMD.

Scalable Innovation

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.