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The FDA released on 8-14-2013 the brand new:

FDA Guidance Radio Frequency Wireless Technology in Medical Devices
(click here for the 14-08-2013 version)

If a cell phone runs a medical application designed to make or part take in a medical decision or health care, then the cell phone is potentially considered and medical device and the supplier is responsible for the applicable regulations.

In summary, the supplier is responsible for:

510(k)  - Premarket Notification (if applicable, or PMA - Pre Market Approval in rare cases)
Quality assurance guidelines during the design and testing phase
Risk Management with Risk-based approach to verification and validation that addresses the topics of


For an evaluation of your concept or product please contact us via e-mail:
Zafirios Gourgouliatos
zafirislosangeles [at] gmail [dot] com

 

Our Services

  • FDA Registration
  • California FDB
    Registration
  • Risk Management
    (plan and execution)
  • 510(k) Submission
    (Pre-Market Notification)
  • Quality System Compliance
        Quality System Part 820
        Templates for small and
        large companies
        Quality System Implementation
        Quality System Audits
  • Crisis Management
        483 Responses
        Warning Letter Response
        Recall Assistance
  • Medical Device
    Safety Testing
  • Technical File
  • Pre-IDE Consulting
  • IDE (Investigational Device Exemption)
  • PMA
    (Pre-Market Approval)
  • Human Factor Study and Performance Testing
  • United States Agent/Official Correspondent Services
  • ISO Registration, CE Marking
  • DMEPOS Accreditation
  • DME/HCPCS Code
    Application
    HIPAA Compliance
  • Health Canada
    Registration
  • EU Representation

  

  

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