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Are These IT Challenges Putting Your Operations at Risk?
Charles IT helps medical device manufacturers stay compliant, protect IP, and keep systems running smoothly—from R&D through production. Align with FDA and ISO standards while building a secure IT environment that supports innovation.
- Struggling to meet FDA compliance IT support and documentation requirements across your product lifecycle.
- Navigating ISO 13485 IT compliance services without dedicated internal expertise.
- Inconsistent network security exposing you to breaches.
- Lack of centralized, secure systems for managing R&D and production workflows.
- Difficulty finding IT support who understands industry-specific regulatory demands.
- Outdated infrastructure slowing innovation and failing to support scalable growth.
IT Solutions for Medical Device & Equipment Manufacturing
Tailored for high-precision, high-demand environments.
Our IT services support every stage of your medtech operations, from product design to production and beyond.
- FDA and ISO-Aligned IT Compliance Services
- 24/7 Network Monitoring and Cybersecurity Solutions
- Cloud-Based Infrastructure and Data Management
- Disaster Recovery and Business Continuity Planning
Compliance & Cybersecurity Aligned with
Medtech Standards
Support for regulatory frameworks from R&D to post-market.
HIPAA
CMMC
DFARS
SOC 2
NIST CSF
FINRA
External Vulnerability Scanning
Security Awareness Training
Endpoint Encryption
Security Information & Event Management
Multi-Factor Authentication (MFA)
Dark Web Monitoring
Managed Detection & Response (MDR)
Backup & Disaster Recovery
Public Cloud
Private Cloud
Managed VoIP Phones
Email Solutions
Proactive Support
Unlimited Support
What Results Can You Expect?
Medical device manufacturers typically see:
- Streamlined FDA and ISO 13485 compliance processes, with documentation.
- Reduced system downtime and faster resolution times, ensuring smoother operations.
- Enhanced data protection and IP security through layered cybersecurity strategies.
- Improved scalability and performance with infrastructure that grows with your product development lifecycle.
Resources
Frequenly Asked Questions
Charles IT offers secure, scalable IT support for medical device manufacturers, including network management, cybersecurity, compliance assistance, cloud infrastructure, and 24/7 helpdesk support—tailored to the needs of regulated healthcare technology companies.
We help medical device companies meet FDA, ISO 13485, and other regulatory standards through secure systems, audit-ready documentation, risk assessments, and IT controls that align with quality management and validation requirements.
Yes. We provide advanced cybersecurity solutions including endpoint protection, encrypted backups, secure file sharing, and threat detection to protect proprietary product data, designs, and clinical trial information.
Absolutely. We enable secure remote access and collaboration tools to support research, engineering, and compliance teams—whether on-site, remote, or across multiple locations.
Medical device firms trust Charles IT for our healthcare IT expertise, fast response times, and regulatory knowledge. We deliver IT solutions that reduce risk, protect innovation, and keep product development on track.
