MedDev Soft
MedDev Soft specializes in providing comprehensive solutions for the development, certification, and regulatory compliance of medical software and devices. They focus on simplifying market access for digital health and medical devices by offering services such as software quality assurance, verification and validation, cybersecurity, risk management, consulting, and regulatory compliance, including ISO standards. With a strong emphasis on adherence to international standards like ISO 13485, ISO 14971, and ISO 27001, MedDev Soft aims to ensure the safety, efficacy, and quality of medical devices and software, facilitating global market access and patient safety.
Industries
Nr. of Employees
small (1-50)
MedDev Soft
POB: 289, Ramot Menashe, 1924500, Israel
Services
End-to-end SQA services for medical device software including test strategy, test execution, defect tracking, artifact traceability and audit-ready documentation.
V&V services covering unit, integration and system testing, protocol/report generation and validation of development/quality tools.
Regulated software development and secure SDLC implementation for medical device software and SaMD, including architecture, algorithms and IEC 62304-aligned processes.
Threat modeling, vulnerability assessment, cyber security plan/report development, SBOM management and regulatory alignment (FDA, MDR, NIST, ISO 27000, HIPAA/GDPR).
Regulatory strategy, device classification assistance, premarket guidance and implementation/management of ISO 13485, ISO 14971 and ISO 27001 QMS/ISMS.
Risk framework development and operational risk management aligned with ISO 14971 covering design, production and postmarket monitoring.
End-to-end SQA services for medical device software including test strategy, test execution, defect tracking, artifact traceability and audit-ready documentation.
V&V services covering unit, integration and system testing, protocol/report generation and validation of development/quality tools.
Regulated software development and secure SDLC implementation for medical device software and SaMD, including architecture, algorithms and IEC 62304-aligned processes.
Threat modeling, vulnerability assessment, cyber security plan/report development, SBOM management and regulatory alignment (FDA, MDR, NIST, ISO 27000, HIPAA/GDPR).
Regulatory strategy, device classification assistance, premarket guidance and implementation/management of ISO 13485, ISO 14971 and ISO 27001 QMS/ISMS.
Risk framework development and operational risk management aligned with ISO 14971 covering design, production and postmarket monitoring.
Expertise Areas
- Medical device cybersecurity and SBOM management
- Software quality assurance (SQA) and test strategy
- Verification & validation (unit, integration, system)
- Regulatory strategy and premarket guidance (FDA, MDR, IVDR)
Key Technologies
- Machine learning / AI
- Secure software development lifecycle (Secure SDLC)
- Software Bill of Materials (SBOM) management
- Cloud-based architectures and secure storage