COMPLIANCE

Compliance Standards

NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd. is committed to achieve excellence by designing, manufacturing and delivering the highest quality products and services. The satisfaction of our customers' expectations and their clients' needs is fundamental to our success.

NeuroLogica Corporation's Quality System complies with FDA QSR, CMDR, and the MDD 2007/47/EC requirements for medical devices. The Quality System has been assessed and holds an ISO 13485:2003 Certification from Intertek Testing Services NA, Inc., a leading registrar. Additionally surveillance audits are conducted by other notified bodies for compliance with CFDA (China), MFDS (Korea), JPAL (Japan) and INMETRO (Brazil).

Customer Assurance

NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd. is committed to providing quality products and services to our customers.  This commitment ensures that we support continuous quality improvement programs and monitor the level of customer satisfaction.

We have a dedicated team of quality professionals that work closely with Sales, Customer Service and Clinical Application Specialists to provide the highest level of service and customer satisfaction.

We appreciate your feedback on your experiences with our products, and services.  Please feel free to contact the Quality Department at customerassurance@neurologica.com.

Health Insurance Portability and Accountability Act of 1996 (HIPAA) Compliance

NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd. has established an official policy to ensure the Security and Privacy of individual’s health information including providing notification of any security breach of unprotected patient health information needed to analyze patient safety events.  Duties include, but are not limited to administrative actions, policies and procedures, managing selection, development, implementation and maintenance of security measures to protect Patient Health Information (PHI).  

Restriction of Hazardous Substances (RoHS)

NeuroLogica Corporation’s Environmental Policy identifies the company’s commitment for ensuring our medical products and their accessories comply with relevant global environmental legislation and regulations pertaining to the use of restricted hazardous materials.

EU Directive 2011/65/EU (RoHS) restricts the use of six substances in electrical and electronic products: Lead (Pb), Mercury (Hg), Cadmium (Cd), Hexavalent chromium (Cr6), Polybrominated biphenyls (PBBs) and Polybrominated diphenyl ethers (PBDEs).

Product compliance is assured when considering the application of appropriate EU RoHS II exemptions classified within Annex IV to Directive 2011/65/EU of the European Parliament and of the Council until July 2017.

China RoHS (Management Methods for Control of Pollution from Electronic Information Products) requirements for imaging systems are labeled for all products manufactured as of April 2013 demonstrating labeling compliance for both the equipment and its packaging. 

Healthcare Professionals Expenditures Reporting

NeuroLogica Corporation, a subsidiary of Samsung Electronics Co., Ltd. has developed a policy that defines our code of conduct for Healthcare Professionals Expenditures Reporting, which meets both federal and state guidelines. NeuroLogica Corporation follows the ethical standards and compliance of the National Physician Payment Transparency Program – Open Payments  (Sunshine Act).

If you have any questions or concerns pertaining to the data reported and/or our compliance program, please contact customerassurance@neurologica.com.

National Electrical Manufacturers Association (NEMA)

Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA) introduced the XR-29 Standard Attributes on Computed Tomography (CT) Equipment Related to Dose Optimization and Management that helps health care providers optimize the radiation dose a patient receives from computed tomography (CT) scanners.

To find out if your system is compliant with the XR-29 Standard (MITA Smart Dose), please click here.

 

RoHS Compliant
INTERTEK Compliant
Brazilian Compliant
EC Compliant

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