Software as a Medical Device (SaMD)

Software as a medical device

Gener8 specializes in developing Software as a Medical Device (SaMD)

Ensuring compliance with global regulatory standards while delivering
high-performance, innovative solutions for the healthcare industry.

What is Software as a Medical Device?


SaMD, or Software as a Medical Device, is software designed for medical purposes without depending on specific hardware. According to the FDA, SaMD functions independently to support medical decision-making, diagnostics, and treatment.

Common examples:

  • Mobile medical applications
  • AI-driven diagnostic tools
  • Medical image analysis software

Looking to develop a SaMD product?


Let’s work together to create a compliant, secure, and innovative solution.

  • Expertise in SaMD regulations & technology
  • Seamless integration with cloud, mobile, and Healthcare IT systems
  • Dedicated support from concept to post-market maintenance

Gener8’s Expertise
in SaMD Development

 

Regulatory Compliance
& Quality Assurance

  • Full compliance with FDA, EU MDR, and IEC 62304 standards
  • A streamlined pathway from concept to regulatory approval
  • Documentation support for regulatory submissions

Core Capabilities

Our SaMD experience  includes:

  • Clinical decision support – AI-driven tools to assist healthcare professionals
  • Remote monitoring – Continuous patient data tracking and real-time insights
  • Data analytics – Advanced processing to improve diagnostics and treatment outcomes

Risk Management & Cybersecurity

  • Applied security measures to protect patient data
  • Compliance with industry cybersecurity standards for remote and wireless applications
  • Proactive risk assessments to identify and mitigate vulnerabilities

 

Proven Approach

Proven Methodology

Proven Performance

IEC 62304 Compliance

  • Tailored processes that align with varying risk levels
  • Ensures regulatory requirements are met in both US and EU markets

Custom Development Approach

  • Flexible iterative development to match your vision and needs
  • Versed in multiple development methodologies such as Agile and Iterative Waterfall
  • Budget-conscious and timeline-driven execution

End-to-End Development Lifecycle

From initial concept to post-market support, we handle every phase:

  1. Concept & Prototyping
  2. Development & Testing
  3. Regulatory Approval & Compliance
  4. Post-Market Monitoring & Updates

Don’t let these challenges derail your project.

Gener8 is here to help -
let’s talk.

Addtional Specialized Software Services

At Gener8, we provide tailored software solutions designed for the unique needs of medical devices, life sciences, and biotech industries.
Whether you’re developing a standalone digital health application or embedded software for laboratory instruments, our expertise ensures a seamless 
path from concept to regulatory approval.

Instrument Software

✔ Custom Solutions for Diagnostics & Analyzers – Optimized for accuracy and efficiency.


✔ User-Friendly Interfaces – Intuitive UI/UX design for effortless operation.


✔ Workflow Automation & Data Processing – Streamlining lab processes with smart software.

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SaMD

(Software as a Medical Device)

✔ Clinical Decision Support & Remote Monitoring – AI-driven insights and real-time patient tracking


✔ Regulatory-Ready Software – Built to meet FDA, EU MDR, and IEC 62304 standards.


✔ Seamless Development-to-Approval Process– End-to-end support for faster market entry.

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Cybersecurity

✔ Security Embedded in Every Development Phase – Protecting against vulnerabilities from the start


✔ Comprehensive Risk Assessment – Identifying and mitigating cybersecurity threats.


✔ Software Bill of Materials (SBOM) Compliance– Ensuring transparency and security in your tech stack.

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Cloud Solutions

✔ HIPAA-Compliant Platforms – Securely managing patient and research data.


✔ IoT Integration & Real-Time Connectivity– Seamlessly linking devices and cloud-based systems.


✔ Remote Diagnostics & Collaboration – Enabling multi-user access and global monitoring.

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Verification and Validation

✔ End-to-End Testing for FDA & EU MDR Approval– Reduce risk with rigorous validation.


✔ Independent Testing Teams– Unbiased verification for enhanced reliability.


✔ Software Tool Validation – Meeting compliance standards for development tools.

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QMS

(Quality Management System)

✔ Pre-Submission Review– Identifying and closing compliance gaps before regulatory submission.


✔ Flexible Integration– daptable to your existing QMS or our industry-tested system.


✔ Tailored Compliance Solutions– Ensuring smooth adaptation to evolving regulations.

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Browse Software Case Studies

Software Engineering for a New Generation of Electroporation Cell Therapy Instrument

March 29, 2023

Acquisition Assessment and Remediation

September 21, 2023

Development of Next Generation Sequencing (NGS) Companion Diagnostic Device

September 27, 2023

Convergent Dental Partners with RND Group to assist with Solea System

October 13, 2023
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Thousands of projects completed.

We’re proud to serve the Biotech, Medical, and Industrial markets.

Instruments & Devices
1,650+
Microfluidic Cartridges & Consumables
500+
Clients
400+
Software Development
100+