SaMD Advisory

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Harnessing AWS's Dynamic Environment

Our expertise in AWS transforms SaMD development:

• Amazon EC2: Unlock scalable compute capacity tailored for varying SaMD needs.
• Amazon RDS: Leverage relational databases to ensure smooth and efficient data management.
• AWS Lambda: Run your SaMD code without explicit provisioning or managing servers.
• Amazon S3: Store vast volumes of medical data with uncompromised security and easy retrieval mechanisms.
• AWS Conformance Packs: Implement governance frameworks at scale, ensuring adherence to regulatory stipulations and internal best practices.

Sailing Through Azure’s Versatile Ecosystem

We guide SaMD solutions to harness Azure's potential:

• Azure Kubernetes Service (AKS): Optimize container orchestration, ensuring your SaMD applications are seamlessly scalable.
• Azure Cognitive Services: Infuse AI capabilities into your SaMD, from voice recognition to visual analytics.
• Azure SQL Database: Implement robust data management strategies tailored for intricate healthcare data.
• Azure Security Center: Safeguard your SaMD solutions with multi-layered security from endpoints to databases.

Crafting and advising on Software as a Medical Device (SaMD) isn’t just about understanding software or medical guidelines in isolation. It demands a delicate balance of clinical insights, technological prowess, regulatory comprehension, and hands-on experience in healthcare systems. Meet our ideal SaMD advisory team, handpicked to provide a comprehensive, holistic approach to your SaMD initiatives.

• Role: Ensures that the SaMD meets actual clinical needs, provides valuable clinical insights, and integrates effectively into clinical workflows.
• Background: Medical degree with years of experience in clinical settings, combined with familiarity with medical software applications.

• Role: Designs the technical foundation of the SaMD, ensuring scalability, interoperability, and robustness.
• Background: Computer science or software engineering with a specialization in cloud platforms like AWS or Azure and prior experience in healthcare IT solutions.

• Role: Ensures that the SaMD adheres to all necessary regulations, including FDA guidelines, and is prepared for regulatory scrutiny.
• Background: Background in law or healthcare with specialized training in FDA regulations, especially CFR 21 Chapter 11, and other international SaMD guidelines.

• Role: Harnesses data to improve the SaMD’s functionalities, performance, and clinical impact.
• Background: Advanced degree in data science or related field with experience in medical data analytics, machine learning, and AI.

• Role: Designs intuitive user interfaces, ensuring ease of use for both clinical and non-clinical stakeholders.
• Background: Degree in design with specialization in UX/UI, especially for medical or healthcare applications.

• Role: Ensures the SaMD functions correctly, is free from critical bugs, and adheres to quality benchmarks.
• Background: Computer science or related field with special training in software quality assurance, particularly in the health tech domain.

• Role: Coordinates the team’s efforts, ensuring that the SaMD project remains on track, within budget, and aligned with stakeholder objectives.
• Background: Degree in management or a related field, with certifications like PMP or PRINCE2, and a strong track record in overseeing medical software projects.

• Role: Ensures that the SaMD, its data, and interactions are secure from external threats, adhering to strict patient privacy regulations.
• Background: IT or cybersecurity degree with a focus on healthcare applications, HIPAA compliance, and cloud security protocols.