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INDUSTRIES

IT Solutions for Medical Device Companies

Secure, Compliant, and Scalable Infrastructure from R&D to Deployment

 

 

 

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Industry-Specific Challenges:
Complex Systems, High Stakes

 

Medical device companies operate at the intersection of healthcare innovation and regulatory scrutiny. From prototyping to post-market support, each phase presents critical IT challenges.

 

Common Pain Points Include:

 

>  Strict FDA validation requirements for design controls and manufacturing systems

>  Software Development Lifecycle (SDLC) documentation and infrastructure compliance

>  Securing connected devices (IoT/IoMT) across distributed environments

>  Storage, analysis, and protection of high-volume telemetry data

>  Cross-functional collaboration between R&D, engineering, and quality teams

>  Ongoing compliance with ISO 13485, IEC 62304, and 21 CFR Part 11

 

When patient safety, product approval, and market timing are on the line, your IT strategy must be as advanced and resilient as your devices.

Purpose-Built IT Solutions for
the Medical Device Industry

Sourcepass delivers secure, validation-ready IT environments that support innovation while meeting the highest standards of compliance, connectivity, and performance.

FDA-Ready Validation & Documentation

  • Infrastructure aligned with FDA and ISO 13485 requirements

  • Complete documentation to support design control and validation efforts

  • Audit preparation and support for 21 CFR Part 11 compliance 

IoT & Connected
Device Security

  • Secure onboarding and lifecycle management for connected and implantable devices

  • Firmware and patch management, encryption, and network segmentation

  • Endpoint protection and zero-trust security models for IoMT deployments 

Cloud Infrastructure for Data Capture & Analytics

  • Scalable, HIPAA-ready cloud platforms to store and analyze device-generated telemetry

  • High-performance computing for simulation, testing, and data modeling

  • Backup and disaster recovery solutions for continuous availability

SDLC & DevOps Support

  • Environments tailored for medical device software development and validation

  • Governance and access control across the full software lifecycle

  • Collaboration platforms for agile, cross-departmental workflows 

 

Strategic IT Support Across the Product Lifecycle

  • Identity and access management for distributed teams

  • Procurement and vendor management to streamline development and deployment

  • 24/7 support via our U.S.-based help desk and Quest® platform 

 

 

Why Engineering Firms Choose Sourcepass

Medical device firms choose Sourcepass because we bring more than just IT services.

We deliver strategic guidance, compliance expertise, and high-touch support tailored to the unique demands of your industry.

>  Proven experience supporting regulated life sciences environments

>  Infrastructure and documentation built for audit-readiness

>  Expertise in IoT security and telemetry data workflows

>  Agile support models to scale with your R&D and manufacturing needs

>  Transparent service with real-time access through our Quest® platform

About Sourcepass

Sourcepass is a national managed IT and cybersecurity provider supporting healthcare and life sciences innovators.

With a commitment to excellent service and strategic guidance, we help medical device companies scale faster, meet compliance demands, and innovate securely.

From concept to market, Sourcepass ensures your IT infrastructure never slows you down.

Learn more >

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A Next Generation IT Experience

Quest® by Sourcepass is a next-generation IT management platform that delivers full transparency, exceptional service, and intelligent automation—all in one place.

With real-time ticket tracking, project updates, and streamlined employee onboarding, Quest® puts you in control of your tech ecosystem from desktop or mobile. It's IT made smarter, faster, and fully aligned with your business.

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Dedicated to excellence.

Sourcepass has achieved SOC 2 Type II and ISO 27001 certifications, reflecting our commitment to safeguarding the confidentiality, integrity, and availability of data, environments, and cybersecurity processes for both customers and trusted partners alike.

Build an IT Foundation That’s Audit-Ready and Innovation-Friendly

Schedule a consultation to see how Sourcepass can help you stay compliant, secure, and ready for growth.