Compliance

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 21 CFR Part 820 (Quality System Regulations) and has been assessed to ISO 13485:2016 requirements. Additionally, surveillance audits are conducted by Notified Bodies and our Registrar for compliance with EU Medical Device Regulation 2017/745, NMPA, MFDS (Korea), MHLW MO 169, TGA and RDC ANVISA 16/2013.Our facility is in compliance with Massachusetts Radiation Control Program regulations, including 105 CMR 120.000.

NeuroLogica Corporation's Executive Management is committed to excellence by dedicating ourselves to the following:

Innovation to deliver products and features that are designed to exceed our customer requirements and expectations
Providing a safe work environment
Maintaining and meeting a documented quality management system that complies with ISO 13485 and requirements of the global regulatory authorities
Building a culture where employees are encouraged to make decisions and act proactively with a sense of ownership, based on mutual respect of individuality and trust
Increasing coverage so that all patients and markets have access to our products and services
We have a team of quality professionals that work closely with Engineering, Sales, Manufacturing and Service departments to ensure that our company consistently meets customer and applicable regulatory requirements. We appreciate your feedback on your experiences with our products and services. Please feel free to contact the Quality team at compliance@neurologica.com

NeuroLogica has established an official policy to ensure the security and privacy of individual’s identifiable health information, including providing notification of any security breach of unprotected patient health information (PHI) 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 PHI.

NeuroLogica’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.

NeuroLogica’s Code of Conduct sets guidelines that define ethical business practices and conduct related to the interactions with healthcare professionals, which meets both federal and state regulatory requirements. 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 or our compliance program, please contact compliance@neurologica.com

NeuroLogica’s specific policy on anti-bribery and anti-corruption sets guidelines that, in the conduct of work for, or on behalf of NeuroLogica, no one is permitted to offer, promise, approve, provide and agree to receive or accept any improper payment or anything of value. This includes anything for the purpose of improperly obtaining or retaining business or a business advantage, in return for improperly directing business to the payer or for the purpose of improperly affecting an individual who may influence the business interest of Samsung.

NeuroLogica provides a solution to support our customers by offering the tools to protect against cyberthreats. Samsung’s Cybersecurity Solution strives to abide by the CIA triad (Confidentiality, Integrity, and Availability) and takes a comprehensive approach to providing impeccable protection with the following pillars: Intrusion prevention, Access control, and Data protection. Our company publishes responses to important cybersecurity threats and vulnerabilities on this link: https://www.neurologica.com/cybersecurity