Business Details
Custom Medical Device Software Solutions
Rnd Group has been a trusted partner in medical device software development for over 25 years. Our team of engineers specializes in creating FDA-compliant solutions tailored to the unique needs of healthcare clients. We offer end-to-end services including custom software development, cloud integration, LIS connectivity, and quality system compliance assessments. Our expertise spans the full lifecycle of medical device software, from initial design to post-market support. With an average of 15+ years of experience, our engineers deliver solutions that meet rigorous regulatory standards while accelerating time-to-market. We prioritize collaboration, working closely with clients to ensure their vision aligns with quality and compliance requirements.Our commitment to innovation is reflected in our proven track record of successful FDA submissions for 75+ medical devices. We maintain a culture of continuous learning and technical excellence, ensuring our team stays at the forefront of medical software development advancements. Our cloud-based Device Management Portal and Application Accelerator framework demonstrate our ability to solve complex challenges efficiently. As a recognized leader in the industry, we combine technical proficiency with strategic partnership to deliver life-changing medical technologies.
Services
Custom Development
Cloud Solutions
Quality Assessment
Technical Evaluation
Software Verification
LIS Integration
Device Management
FDA Readiness
Application Accelerator
Verification Validation
Highlights and features
- We have 25+ years of experience in medical device software development
- Our engineers average 15+ years of specialized industry expertise
- We specialize in FDA-compliant software solutions for regulated environments
- We offer LIS and EHR integration services for medical devices
- Our cloud solutions meet HIPAA guidelines and cybersecurity standards
Associations and certifications
- ISO 13485
- FDA 21 CFR Part 820
- IEC 62304
What people say
Life-changing work
FDA approval success
Expertise in medical software
Timely delivery
Strong team collaboration
Services
Custom Development
We create custom software solutions specifically designed for medical devices. Our team translates complex biomedical algorithms into testable code while ensuring FDA compliance. With expertise in both embedded systems and cloud-based applications, we deliver solutions that meet rigorous regulatory requirements while maintaining intuitive user interfaces aligned with CLIA regulations.
Cloud Solutions
Our cloud solutions specialize in medical device data systems and secure connectivity. We implement HIPAA-compliant architectures with proper encryption and authentication protocols. Our cloud-resident applications support secure LIS integration and remote diagnostics, ensuring compliance with FDA cybersecurity guidelines while maintaining seamless data flow between medical devices and healthcare information systems.
FDA Readiness Assessment
This service provides independent assessment of FDA submission readiness. We evaluate quality systems and design documentation against IEC 62304 and FDA cybersecurity standards. Ideal for companies developing first medical devices or transitioning research-use devices to clinical applications, our assessment includes detailed compliance reports and corrective action roadmaps to ensure successful FDA submissions.
LIS Connector
Our LIS Connector enables immediate connectivity between medical devices and laboratory information systems. Supporting HL7, ASTM, and POCT1-A protocols, this solution saves months of development time. The customizable platform works with Windows and Linux environments, providing secure data exchange while maintaining compliance with regulatory standards for medical device software.
Device Management Portal
This cloud-based portal enables secure instrument management through web interfaces. Features include software updates, diagnostic data collection, and usage monitoring. The multi-tenant architecture supports organizational management and comprehensive reporting while meeting FDA cybersecurity requirements. This solution eliminates the need for field service deployments through remote troubleshooting and update capabilities.
People
Stephanne Flint
Vice President of Software
Specializes in medical device software development with expertise in ISO 13485 and FDA compliance. Led distributed engineering teams for major medical device launches. Manages projects from concept to market while maintaining quality system adherence.
Brad Graves
Director of Software
30-year software development veteran with 15 years in healthcare. Manages medical device projects while providing regulatory and technology consulting. Oversees quality assurance processes and leads strategic initiatives for software development compliance.
Matt Verner
Director of Software
20-year RND Group veteran managing customer projects and IT infrastructure. Serves as project leader and architect for laboratory instruments. Former IBM software engineer with extensive experience in regulated medical device software development environments.
Chris Gray
Director of Software
Led numerous medical device projects through product lifecycle phases. Brings strong quality assurance background to regulated environments. Manages software verification processes and compliance documentation for FDA-submitted devices.
Nathan Plant
Senior Manager, Quality & Compliance
20-year medical device quality engineering specialist. Oversees quality team operations and ensures compliance with multiple regulatory standards. Focuses on software quality assurance and risk management for FDA-regulated medical device software.
Questions
What medical device software services do you offer?
We provide custom development, cloud solutions, FDA readiness assessments, LIS integration, and device management portals for medical devices.
How do you ensure FDA compliance?
We follow ISO 13485, IEC 62304, and FDA 21 CFR Part 820 standards with dedicated quality assurance teams and verification processes.
Can you help with LIS/EHR integration?
Our LIS Connector provides immediate connectivity using HL7, ASTM, and POCT1-A protocols for seamless medical device integration.
What experience do you have?
25+ years in medical software with engineers averaging 15+ years' experience, supporting 75+ FDA-approved devices.
Do you offer cloud-based solutions?
Yes, we develop HIPAA-compliant cloud applications and MDDS systems with secure authentication and encryption protocols.
How do you manage device updates?
Our Device Management Portal enables remote software updates, diagnostic data collection, and usage monitoring through secure cloud infrastructure.
