Regulatory Information
NeoCoil designs and manufactures each product to ensure the highest quality and is committed to excellence in everything we do. Our precision in engineering and manufacturing showcases our dedication to providing the best in medical imaging technology.
Quality Management System
NeoCoil, LLC maintains ISO 13485:2016 and MDSAP certifications
ISO 13485 quality system certification
MDSAP certification (USA, Australia, Brazil, Canada, Japan)
Certificates can be verified at:
https://www.bsigroup.com/en-US/validate-bsi-issued-certificates/
Notified Body / Registrar Information
NeoCoil, LLC is audited each year by:
BSI Group The Netherlands B.V.,
A Member of the BSI Group Holdings B.V.
Contact Office
John M. Keynesplein 9
1066 EP Amsterdam
The Netherlands
Registered in The Netherlands under number 33264284
Global Regulatory Representatives
Shown below are in-country representatives for regulatory affairs issues and incident reporting.
To request a product Declaration of Conformity, or for inquiries related to worldwide distributors and/or regulatory representation for countries/jurisdictions not listed, please contact: [email protected]
EUROPE - Authorized Representative
EMERGO EUROPE
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
Phone
+31.70.345.8570