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NORDICNEUROLAB 11/22/2017

NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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Page 1: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

NORDICNEUROLAB

11/22/2017

Page 2: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

11/22/2017

Page 3: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

11/22/2017

Visual cortex

Page 4: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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Page 5: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

11/22/2017

Auditory cortex

Page 6: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

Brain MRI without fMRI Brain MRI with fMRI

11/22/2017

Page 7: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

Displayed in our software it would look like this

11/22/2017

Page 8: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

COMPANY INFORMATION

11/22/2017

Page 9: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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

Page 10: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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

Page 11: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory
Page 12: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

11/22/2017

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 %

Page 13: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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

Page 14: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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)

Page 15: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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

11/22/2017

Page 16: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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

Page 17: NORDICNEUROLAB - Bergen Næringsråd...NNL’s holds certification to the following standards • ISO 13485:2003-Medical devices- Quality management systems- requirements for regulatory

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