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SaMD Software
Development Services

We bring the best of Validation, Quality
Management and Modern Software Development
to the world of Software as Medical Device

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SaMD and AI – A Breakthrough in Patient Care

With the increasing adaptation of AI in healthcare, SaMD solutions have seen increased adaptions in healthcare because of the breakthroughs they provide especially in CDSS and Digital Therapeutics. But, the success of SaMD commercialization depends upon the use case and modern software development approach.

AIMDek SaMD Expertise

SaMD Diagnostic
  • Medical Imaging Analysis
  • Predictive ML models for disease prediction, interventions

SaMD Monitoring Solutions
  • Chronic Disease Management Software
  • Remote Patient Monitoring Solutions​

Digital Therapeutics SaMD
  • Evidence-based therapeutic intervention Software
  • Rehabilitation Applications

Clinical Decision Support Systems (CDSS)
  • SaMD for diagnosis suggestions
  • Treatment Plan recommendation SaMD solutions

Wellness and Telemedicine Solutions
  • Personalized physical and mental wellness applications
  • Medication Dosages and management applications

We Personalize Our Approach Based on Our Client’s Expertise

SaMD Development for Healthcare Providers and Medical Practitioners
  • Technical Feasibility Services
  • PoC and Wireframing Services
  • MVP Development
  • RFP Submissions guidance for grant approvals
  • Technology Experts for CoE
SaMD Development for Private Equity Investors and Venture Capitalists
  • Micro-venture Technology Partnerships
  • Commercial and Technology Due Diligence
  • Post-close engineering, optimization and modernization services
  • SaMD future roadmap, SDK improvements for Value optimization
SaMD for Independent Software Vendors (ISVs)
  • SaMD Experts for CoE
  • AI/ML development
  • Emerging Technology Assistance (Gen AI, Deep Learn ML, Data Visualization solutions)
  • Technology Partnership to establish an extended team

AIMDek SaMD Offerings

SaMD Consulting
  • PoC and Technical Feasibility
  • Integration Partnership
  • QMS alignment with Software Development
  • AI/ML CoE experts
  • Defining development best practices
  • Information Architecture and Interoperability compliance

SaMD Verification and Validation
  • Shift from QA to QE V&V
  • Software Validation Automation
  • Agile QE practices
  • Outcomes-focused test-case writing

SaMD Software Development
  • Agile Development Services
  • Web Application Development
  • Native Mobile App Development
  • SDK Development for integration partnerships

AI/ML Development
  • AI/ML Algorithm development
  • Deep Learn ML models
  • Effective Quality Monitoring solutions

Regulatory Assistance
  • SaMD classification
  • SaMD premarket submissions
  • Global SaMD solution readiness
  • Integrated and Connected Systems guidance

Cloud Services
  • Cloud Applications Development
  • Cloud infrastructure setup
  • ML model inference optimization
  • Cloud integrations with database
  • Cloud integrations with third-party systems

Innovation Services for AI/ML-driven SaMD companies

  • Cloud Optimization for ML model increased inference
  • Automated Software Validation
  • PCCP submissions during 510 (k) filings
  • Experienced AI/ML experts in algorithm development
  • CoE experts for AI/ML consulting

SaMD + AI Can be Implemented For Many Medical Practices

AI Powered CDSS For Radiology

Enable Radiologists in making informed decisions and accelerate patient diagnostics to increase their efficiency and optimize the time they invest in a case.

Hyper fast Vascular Imaging Capabilities

Get real-time alerts and insights with Deep Learn Trained ML models hosted on high inference networks for effective treatments and coordinated care.

Revolutionize CVD prevention in Cardiovascular Care

Design-led product and platform innovations for menopause care

Use of AI in Neurovascular Diseases

Establish streamlined multidisciplinary workflows and seamless coordination across networks for efficient patient care and detection in Neuro.

AI for Automated Insulin Delivery

Create AI powered solutions for Automated Insulin Delivery Medical Devices for Type 1 diabetes care and automated glucose management.

AI Revolutionizing FemTech

From AI powered Menstrual pain management, reproductive health to use of Deep Learn ML in Cerivcal and Breast Cancer detection, AI can change Women’s healthcare completely.

Employ the AIMDek Edge

ISO 13485, IEC 62304 and ISO 14971 compliant development practices

Automated Validation Frameworks, Techniques and Solutions

Agile Development and QE Practices

FDA, EU MDR, DiGA and GDPR regulatory expertise

AI/ML Expertise