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510(k) Medical Solutions   

FDA & 510(k) Solutions 

 

Medical devices are increasingly complex and your medical products need a competitive advantage: Software. Highly Reliable Embedded Software from HighRely.

Our medical software solutions and internal FDA-compliant processes encompass:

  • Regulatory Compliance (Process compliance to ANSI/AAMI/IEC 62304) - We focus on what is necessary - doing what is required and only what is required.
  • Staff Augmentation - Through our diverse expertise, we help free up your team. 100% U.S.
  • Tools and Equipment - We utilize the most advanced, modern software development tools and electronic test equipment for medical device development.
Our emphasis is on cost-effective technically superior solutions with first-time 510(k) approvals:
  • Checklists - FDA Compliance Checklists are required for 510(k) / PMA. HighRely has them.
  • Verification - Develop In-House Test Platforms for SW Unit Level Testing & Automation scripts to expedite your schedule.
  • Program Management - Verification of risk control measures. Risk Management of software changes.
  • Training - Reducing development and certification costs, schedule, and risk.
  • Reverse-engineering and GAP analysis: Getting credit for pre-existing software without starting from scratch.
  • Utilizing FDA's 510(k) & PMA development processes - comply with the FDA's requirements:
    • Architectural Mitigation
    • System Safety Assessment Processes
    • COTS Components Usage
    • Product Service Experience
    • 3rd party hardware design tools
    • Information Flow (System Development Process <> HW Design Life Cycle Process)
    • Advanced Validation & Verification Methods
See HighRely's Whitepapers for the best practices & recommendations in Medical Device Software Development:
  Software tips for successful 510(k) submissions.  
  Medical Device Software Development for FDA 510(k) QSR/GMP Success.  
  Avoiding The Top 10 FDA 510(k) QSR Medical Device Software Development Mistakes.
Contact info<at>highrely-dot-com for more information

 

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