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We at Brainlab are fully committed to high ethical standards and aim to act with integrity and compliance in our daily work.

For us, mutual respectful conduct, reliability and responsibility as well as fair competition and working conditions are inseparably linked with compliance and constitute the basis for all business-related activities. This also comprises the protection of human rights and respecting our environment.

To prevent incompliant or criminal conduct of any kind, we have developed an Integrity & Compliance Program that addresses legal requirements and supports internal guidelines, procedures and values. Our Compliance Program protects the whole Brainlab group and its respective employees in their decisions and actions in challenging ethical situations and promotes correct and compliant behavior.

Compliance Helpline – Procedure Documentation

Speaking up – The Brainlab Compliance Helpline

Reports on potential or actual criminal conduct or serious non-compliant behavior are of utmost importance for Brainlab and help us to identify problems at an early stage.

Brainlab therefore offers a Compliance Helpline to enable and encourage employees and external parties, like suppliers or customers, to ask compliance related questions, make a suggestion or report possible misconduct within our company. Our Compliance Helpline also covers the requirements of §8 Supply Chain Act (Lieferkettensorgfaltspflichtengesetz LkSG) and shall be used for related reports or complaints as well (§2 Abs 2 and 3 LkSG). These include but are not limited to reports on child labor and forced labor, slavery, human rights- related environmental violations and unequal treatment in employment.

All documents and information provided will be handled with confidentiality and will be carefully reviewed in a timely manner. Information can also be submitted anonymously.

Reporting Procedure

Brainlab offers the following reporting channels:

The Compliance Helpline is accessible via an external, secure website (hosted by an external third party) or by phone with a live operator 24 hours a day in various languages. In many countries Brainlab also offers a toll-free number so you can call at no cost.

For Germany you reach International Toll-Free Service via 0800-1016582 with German or English speaking operators. For other areas numbers are listed in the Helpline’s menu online. Please note the conversation starts with a standard recorded greeting – please don’t hang up.

You can address your reports, questions or concerns:

  • via Email @ [email protected]
  • via Phone @ +49 89 99 15 68 0
  • by Post to: Brainlab Corporate Services GmbH, Compliance, Olof-Palme-Str. 9, 81829 München, Germany

Any reported information must be in good faith and include, to the extent known, the who, what, when and where case details. The more information you provide, the better we can understand and investigate the information you report.

When submitting information, you are free to choose whether to disclose your identity or remain anonymous, provided that this is permitted by applicable laws. In any case the Helpline will provide a report key and password, which will allow you and the Brainlab Professionals to communicate anonymously. It should be noted that if you choose to report anonymously, this may hinder the ability to fully investigate the matter. Further, it may, in certain circumstances, prevent from accessing additional protection at law.

After receipt of any report, we will follow-up with the reporting person and keep him/her informed about the status of the review of the report in accordance with applicable laws.

Investigations will be executed by personnel with experience in dealing professionally with indications of misconduct and the underlying facts. They follow a defined, transparent procedure in order to ensure trust in their objectivity and fairness. All activities of an investigation must be in compliance with legal and professional standards, applicable Brainlab policies & guidelines, as well as performed in an objective and appropriate manner. The following steps will occur when information about potential or actual breaches has been reported:

Step 1: Documentation

  • The Helpline will automatically provide a report key and password, which will allow for further (anonymous) communication and follow-up. For reports via phone or email Brainlab professionals log the alleged breach with an case-ID into the system.
  • If the case is based on a compliance report, an acknowledgment of receipt of the report will be sent to the reporter within seven (7) days.

Step 2: Plausibility Check

  • We undertake a plausibility check.
  • If the report is plausible, a due diligence and investigation will be performed.
  • We might ask the reporting person for more information (if necessary), allowing us to further validate the case.

Step 3: Due Diligence and Investigation

  • Brainlab will execute a diligent review to gain a thorough understanding of issues, facts and circumstances.
  • Potential breach of applicable legal regulations like labor, civil, criminal and data privacy law will be investigated.
  • Only persons suited for this task will be involved based on the “need to know principle”.

Step 4: Closing of Proceedings

  • Based on the findings Brainlab will prepare a written investigation report and a plan for appropriate corrective and preventive actions, including potential sanctions if non-compliance has been confirmed.
  • If the investigation is closed due to lack of sufficient evidence, the suspected person will be informed accordingly.

Step 5: Action plan and Follow-up

  • Brainlab will implement the recommended actions and follow-up on their completion.
  • Brainlab will provide general feedback to the person who made the report within three (3) months. Such feedback shall contain the measures which are or will be taken and why these measures are or will be taken or that non-compliance was not confirmed. If the investigation cannot be closed within three months, an interim feedback is to be provided to the reporter.
  • Brainlab will initiate, if necessary, potential improvement and development measures of the compliance program based on the investigation results to avoid similar occurrences.
  • The documentation of the compliance report including the internal investigation shall be deleted in accordance with Brainlab’s data deletion and retention. For further documentation purposes, reports may be stored in anonymized form.

Brainlab firmly believes that effective reporting structures and an open and transparent culture help to protect the Company, its employees, customers and business partners from damage and reputational harm.

Hence, Brainlab is committed to a policy of non-retaliation. Therefore, employees and any third parties who are awarded protection by applicable laws do not have to fear any negative consequences of discriminatory or disciplinary nature for making a report or raising questions, doubts and concerns. We do not tolerate any kind of threats, detrimental behaviour or acts of retaliation. Such conduct is itself a breach of our values and can result in disciplinary actions.

This Policy of non-retaliation also applies if you are not absolutely certain about the facts, provided you act in good faith. Acting in good faith means that you have reasonable grounds to suspect that, in light of the circumstances and the knowledge available to you at the time of reporting, the information reported is true.

Employees as well as third parties who in good faith seek advice about or report potential or actual criminal conduct, serious non-compliant behaviour or other non-compliant behaviour, have the protection of our Top Management. Any form of retaliation or threat of retaliation is prohibited and subject to disciplinary measures.

Annual Declaration of Compliance with California Law

Brainlab’s annual declaration as set forth in the State of California’s Health & Safety Code §§119400 – 119402 is available here for download.

Code of Conduct and Policy on Interactions with Healthcare Professionals

Brainlab’s Code of Conduct focuses on prevention of non-compliance with applicable laws and regulations and supports us in the implementation of our goals and the company values of Inspiration, Integrity, Simplicity. The Policy focuses on the company’s interactions with Healthcare Professionals. Compliance with the Code of Conduct and the Policy are mandatory for all Brainlab employees worldwide and we fully trust and expect that every employee fulfills this obligation everywhere and every time.

Organizational, Management and Control Model as per Italian Legislative Decree No. 231/2001 – English Version
Organizational, Management and Control Model as per Italian Legislative Decree No. 231/2001- Italian Version

In accordance with Legislative Decree No. 231 of 8 June 2001, Brainlab has adopted a Model. We invite you to read an extract of our Model and kindly ask you to comply with the principles and the conduct described in the Model, which is of fundamental importance for the start and continuation of our business relationship. Should you become aware of any failure to comply with the Model, please inform us accordingly.

Brainlab Japan’s information security basic policy

Brainlab K.K. is providing this policy in compliance with the ISO 27001 information security management standard.