COMPLIANCE

Compliance Standards

Boston Imaging, a subsidiary of Samsung Electronics Co., Ltd. is committed to achieving 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.

Boston Imaging'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 Directive (93/42/EEC), 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.

Quality Policy

Boston Imaging'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 department 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.

Health Insurance Portability and Accountability Act (HIPAA)

Boston Imaging 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.

Restriction of Hazardous Substances (RoHS)

Boston Imaging'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

Boston Imaging's Code of Conduct sets guidelines that defines ethical business practices and conduct related to the interactions with health care professionals, which meets both federal and state regulatory requirements. Boston Imaging 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.

Anti-Bribery and Anti-Corruption

Boston Imaging's’ specific policy on anti-bribery and anti-corruption sets guidelines that in the conduct of work for or on behalf of Boston Imaging, 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

Cybersecurity

Boston Imaging 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.

Samsung’s Digital Radiography systems commercialized by the organization have received a cybersecurity certification known as the Authority to Operate (ATO) for the Risk Management Framework (RMF) program set forth by the United States Department of Defense (DOD). The certification given by the United States government has a stringent set of regulations derived from NIST 800-53 in place regarding the cybersecurity of systems that will connect to government networks and protect the data and integrity of all medical devices.  Samsung pledges to make every effort to comply with the safety, security, integrity and national regulations of its products.