NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards •...
Transcript of NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards •...
NORDICNEUROLAB
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Visual cortex
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Auditory cortex
Brain MRI without fMRI Brain MRI with fMRI
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Displayed in our software it would look like this
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COMPANY INFORMATION
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NordicNeuroLab – who are we?
• Specializes in development and production of hardware and software for functional MRI
• Headquarters in Bergen, Norway, includes production and development
• Sales and service offices in Milwaukee & South Korea
• World wide distributor network
NNL Software for advanced image analysisNNL Hardware for clinical fMRI
Clinical software: BOLD fMRI, DTI and perfusion
analysis
nordicBrainEx
fMRI stimulus presentation
nordicAktiva
Research software: Perfusion, DCE, ASL,
batch etc.
nordicICE
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NL AS
NNL AS NNL Inc.
NNL LtdChina
NNL LLC S. Korea
100 % 100 %
100 % 100 %
Pending
NNL FranceRep. Office
100 %
NNL GermanyRep. Office
100 %
NordicNeuroLab – our installations
• NordicNeuroLab products are used in over 1800 installations in 70 countries world wide
• ISO certified 13485 and 9001
• Focus on regulatory clearances for clinical use of products world wide (CE, FDA, etc.)
• Strong focus on service and support
• More that 15 years experience in the field of functional MRI
NNL’s holds certification to the following standards
• ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory purpose (QMS).
• ISO 9001:2008- Quality management system- requirements (QMS)
• Canadian Medical Devices Conformity Assessment System (CMDCAS): Canadian Medical Devices Regulations (CMDR)
• Medical Device Directive 93/42/EEC (CE- Conformité Européene) European Conformity
• 21 CFR Part 820- Quality system regulations (FDA)
NNL – Market clerances
USA (FDA) HW & SW
Europe (CE) HW & SW
Australia (TGA) HW & SW
South Korea (KFDA) HW & SW
Canada (CMDCAS) HW & SW
Russia (Roszdravnadzor-GOST-R )
HW Only
China (CFDA) SW OnlyHW evaluate
S. Arabia (SFDA) HW and SW
Japan (JPAL- JMDA) SW
Taiwan (TFDA) Evaluate
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Customer overview
Highest ranking cancer hospitals in the US:1. Memorial Sloan Kettering Cancer Center, New York City2. University of Texas MD Anderson Cancer Center, Houston3. Mayo Clinic, Rochester MN4. Dana-Farber/Brigham and Women’s Cancer Center, Boston5. Johns Hopkins Hospital, Baltimore6. University of Washington Medical Center, Seattle7. Massachusetts General Hospital, Boston8. UCSF Medical Center, San Francisco9. UCLA Medical Center, Los Angeles10. Stanford Hospital and Clinics, Stanford BOLD = NNL customer
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