Syncro Medical

Business Details

Medical Device Software Development Experts

Syncro Medical has been a leader in medical device software development for over 30 years, delivering hundreds of successful engineering projects to manufacturers of medical devices, life science instruments, and digital health products. Our team combines deep industry expertise with a culture of craftsmanship, expertise, and integrity to ensure clients achieve regulatory compliance, accelerated time-to-market, and superior product functionality. As ISO 9001, ISO 13485, and ISO 27001 certified professionals, we apply rigorous quality processes to every project, from requirements analysis to deployment. Our agile development methodologies and collaborative approach enable clients to manage risks effectively while maintaining focus on core technologies. With decades of experience in regulated environments, we specialize in translating clinical and technical needs into FDA-compliant software solutions.

Our client-centric philosophy fosters long-term partnerships, with many relationships spanning decades, built on trust, flexibility, and a shared commitment to patient safety. Our SEI-certified architects and engineering teams bring insights from dozens of projects to every engagement, ensuring scalable, maintainable systems that meet evolving market demands. We prioritize early involvement in software architecture to prevent costly rework, while our rapid prototyping capabilities validate concepts before full implementation. Our quality management system aligns with IEC 62304, IEC 62366, and ISO 14971 standards, supporting clients through FDA submissions and global regulatory requirements. By maintaining independent QA teams and documented processes, we guarantee the reliability and performance critical to medical device software success.

Services

Requirements Analysis Software Architecture Rapid Prototyping Regulatory Support Lifecycle Support Embedded Development Cloud Services Mobile App Development Medical IoT Solutions

Highlights and features

We have completed hundreds of medical device software projects since the 1980s.
Our ISO 13485-certified quality system ensures regulatory compliance.
SEI-certified software architects lead every project engagement.
We maintain independent QA teams for rigorous testing processes.
Client relationships often span decades due to consistent delivery performance.

Associations and certifications

ISO 9001
ISO 13485
ISO 27001

What people say

Professionalism and flexibility Worked out far better FDA approved successfully Significant value to business Undivided focus on needs

Website

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Services

Requirements Analysis

Our agile team defines user needs and technical requirements while developing testing plans. We specialize in creating FDA-compliant Software Requirements Specifications through discovery phases that include concept validation and market research. Our ISO-certified processes ensure alignment with IEC 62304 standards for medical device software development.

Software Architecture

SEI-certified architects create scalable frameworks that balance functional requirements with non-functional aspects like security and performance. We document architectures using IEEE standards and conduct periodic design reviews to ensure long-term sustainability while maintaining compliance with international medical device regulations.

Rapid Prototyping

We develop interactive prototypes to test technical feasibility and user workflows before full implementation. Our prototyping services use industry-standard tools to create clickable demos that validate product concepts and reduce development risks for medical devices and digital health solutions.

Regulatory Support

Our ISO 13485-certified quality system provides complete regulatory support for FDA submissions. We document all design processes, conduct code reviews, and maintain traceability matrices to ensure compliance with IEC 62304, IEC 62366, and ISO 14971 standards throughout the software development lifecycle.

Lifecycle Support

We offer ongoing support for medical device software through incremental development cycles. Our services include performance optimization, cybersecurity updates, and regulatory compliance maintenance to ensure long-term product viability in evolving healthcare technology markets.

People

Patrick Carr

President & CEO

Patrick Carr leads Syncro Medical's strategic direction with decades of medical device software development experience. He oversees executive operations while maintaining focus on client satisfaction and industry innovation.

Rick Fisher

VP, Software Engineering

Rick Fisher manages software engineering operations, ensuring technical excellence across all projects. With extensive experience in regulated environments, he leads teams in delivering complex medical device software solutions.

Russ Hill

VP & General Manager

Russ Hill oversees day-to-day operations as VP and General Manager. He brings deep expertise in medical device commercialization and ensures alignment between client needs and technical execution.

Frank Bergmaier

Director, Architecture & Design

Frank Bergmaier leads software architecture initiatives as SEI-certified director. He specializes in creating scalable frameworks that balance functional requirements with regulatory compliance for medical device applications.

Rose Marcantonia

Director, Quality & Process

Rose Marcantonia ensures quality system compliance as Director of Quality. She maintains Syncro Medical's ISO 13485 certification and oversees documentation processes for FDA-regulated software development.

Questions

What medical device software services do you offer?

We provide full lifecycle services including requirements analysis, software architecture, rapid prototyping, regulatory support, and maintenance for medical devices, life science instruments, and digital health products.

How do you ensure regulatory compliance?

Our ISO 13485-certified quality system aligns with IEC 62304, IEC 62366, and ISO 14971 standards. We maintain complete documentation trails and conduct independent QA reviews for FDA submissions.

Can you help with software architecture design?

Yes, our SEI-certified architects create scalable frameworks while balancing functional requirements with non-functional aspects like security and performance through documented IEEE-standard processes.

Do you work with international clients?

We collaborate with medical device manufacturers globally, adapting our processes to meet regional regulatory requirements while maintaining consistent quality standards across all projects.

How do you handle prototype development?

Our rapid prototyping services use interactive demos to validate technical feasibility and user workflows before full implementation, reducing development risks for medical device software projects.

What sets you apart from competitors?

Our 30+ years of medical device specialization, ISO certifications, SEI-certified architects, and client relationships spanning decades distinguish us as industry leaders in regulated software development.

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