Committed to creating bridges between
Medical Device Manufacturers and Markets

RECENTLY ADDED SERVICES:

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

• Wireless Quality of Service

• Wireless coexistence

• Security of wireless signals and data

• Electromagnetic compatibility (EMC) of the wireless technology

• Electromagnetic disturbance (EMD), Electromagnetic interference (EMI), Electrostatic discharge (ESD), Conducted and Radiated emissions

• Latency (the time it takes for a unit of information to cross a wireless link or network connection)

• Quality of service (QoS)

• Data Security

• Specific absorption rate (SAR) by the body of the operator or patient

• Wireless coexistence

• Test Data - Records maintainance

• Labeling (Information for proper set-up and operation, Instructions for Use)

• Considerations for maintenance during the Device Life Cycle

• Advisory Notices to Users, Medical Device Reporting, Recalls

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