Software as a Medical
Device – SaMD

Accelerate your market expansion!

REGULATORY COMPLIANCE:
21 CFR Part 11
EU Annex 11
GAMP5
ISO13485
ISO14971
ISO62304

High-Quality Application

  • State-of-the-art design
  • Market-leading technologies
  • Web-based, cloud-ready solution

Experienced team

  • Nuclear Medicine knowledge
  • SaMD experience
  • Equipment integration & control

Efficient Methodology Framework

  • UI first approach
  • Model-driven Architecture
  • Requirement traceability
ArgonSoft is specialized in developing high-quality software complying with the standards for Software as a Medical Device. Our experts leverages extensive knowledge in nuclear medicine to deliver customized solutions that meet the most stringent industry standards.

Why Choose Us?

  • Expert Team: Our team comprises professionals with deep expertise in software as a medical device development and nuclear medicine.
  • Custom Methodologies: We tailor our development processes to your specific needs, ensuring efficient and effective solutions.
  • Compliance & Quality: We adhere to all relevant standards, including several ISO (62304, 14971, 13485), GMAP5, EUR Annex 11, and 21 CFR Part 11, guaranteeing compliance and quality.

Our Services

Comprehensive SaMD Development

  • From Concept to Deployment: Full-cycle development from initial concept to final deployment.
  • Regulatory Support: Assistance with creating input documents for regulatory submissions and compliance documentation.
  • Validation & Verification: Rigorous testing and validation to ensure safety and reliability.

Customized Solutions

  • Tailored Methodologies: Development processes customized to meet your unique requirements and related standards.
  • Advanced Tools: Utilization of state-of-the-art development tools for superior outcomes.
  • Continuous Improvement: Ongoing enhancements and support post-deployment.

Commitment to Excellence

At ArgonSoft, we are dedicated to transforming healthcare through innovative software solutions. Our commitment to quality and compliance ensures that your medical devices meet all regulatory requirements and function reliably in critical healthcare environments.
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