As a global company with a long history in the medical device industry, Ambu recognizes that our conduct in regard to business ethics, product quality and safety, cyber and data security and supply chain management, has an effect on the world around us. Our governance helps us live up to our external regulations as well as our own high standards.
Business Ethics
Ambu complies with all applicable international laws and regulations and abides by international industry codes such as MedTech Europe and Advamed as a minimum standard.
To help uphold Ambu’s reputation as a company with a high level of integrity and trustworthiness, we have developed the Ambu Code of Conduct for our employees and the Ambu Code of Conduct for Business Partners.
Once a year, all white-collar and indirect blue-collar employees at Ambu must complete an online training course in our Code of Conduct to increase their general awareness of our rules and guidelines for ethical business conduct.
Ambitions and targets for business ethics
We strive to maintain the highest ethical standards by carrying out our business honestly, fairly, ethically and openly, while complying with all applicable laws, rules, regulations and local customary practices.
Our target is a 100% completion rate on our employee online training on the Ambu Code of Conduct.
Explore our progress on our environment, social and governance priorities in our latest Annual Report.
Political contributions
Ambu does not provide financial support to political parties, campaigns, candidates for political office, or any person acting in an official capacity of a political party but may support third-party organizations that provide such support (e.g., regional, national or local industry associations or think tanks). Ambu supports our employees’ right to engage personally in political activity.
Anti-bribery and corruption
Ambu is committed to carrying out its business honestly, fairly and openly and has zero tolerance of bribery and corruption. It is Ambu’s policy to comply with all applicable anti-bribery and anti-corruption laws. Ambu strives to work only with third parties who maintain the same policy.
Product quality and safety
As a producer of medical devices used by hospitals, clinics and rescue services all over the world, Ambu has a great impact on people’s health and safety. We must therefore demonstrate excellence within product governance and ensure that our products and processes live up to all applicable external regulatory requirements for safety and effectiveness.
Unsafe products can directly harm the people on which they are used. Conversely, safe and high-quality products contribute to proper and timely diagnosis and treatment.
Certification
Ambu’s QMS is certified according to:
- ISO 13485
- Medical Device Single Audit Program (MDSAP)
- EU Medical Device Regulation (EU MDR)
- UKCA (UK Conformity Assessment)
Animal testing
In certain situations and countries, animal testing and clinical trial investigations are mandatory during the research and development phase. Such investigations are required to demonstrate the safety and effectiveness of the product as part of the regulatory authorization process or to substantiate the performance of the product in a real-world setting. At Ambu, we aim to replace animal trials with in-vitro studies or chemical characterization tests.
When animal testing is required, we follow all applicable laws and regulations. We follow the ‘Triple R’ principles. This means that we will 'Replace, Reduce and Refine' animal studies used for biocompatibility testing, without compromising patient safety and regulatory requirements whenever possible.
Substances of concern
We strive to design with materials that are benign and inherently good for our users, patients and environment. Likewise, we strive to remove harmful substances on REACH Regulated SVHC substances, RoHS2 and CMR-ED substances from our products.
Learn more about Ambu’s Medical Devices in relation to content of Latex and REACH Regulated SVHC substances
PVC
As a strategic objective to phase out substances of concern from our new products, Ambu will focus on phasing out PVC in all (95%) new product launches . Our aim is to bring down the amount of PVC used in our single-use products to ensure that products will not have a risk of creating harm in the case of incineration.
Phthalates
Ambu products are 100% free from harmful phthalates.
Ambitions and targets for product quality and safety
Demonstrate excellence within product governance, and ensure that our products and processes live up to all applicable external regulatory requirements for safety and effectiveness.
Explore our progress on our environment, social and governance priorities in our latest Annual Report.
Cyber and Data Security
Cybersecurity is critical to operations and protection of intellectual property. Furthermore, it is the backbone for safeguarding assets and data related to our daily operations, our business value and the customers we serve.
Our cybersecurity efforts are risk based and aligns with ISO27001 to ensure robustness and protection of our information assets. Our approach has focus on
- Prevention: We utilise proactive measures to mitigate threats before they materialise
- Detection: We have mechanisms in place to detect various kinds of malicious activity
- Response: We are continually evolving and testing our response capabilities to meet the developing threat landscape.
Ambu is committed to continually improving our security maturity in order to stay focused on emerging cybersecurity threats.
Data privacy and ethics
Ambu recognizes that privacy is a cornerstone in gaining and maintaining the trust of employees, customers, suppliers and business partners. It is Ambu’s policy to maintain the highest ethical standards and comply with all applicable data and privacy laws and regulations. Our work with data ethics is governed by the Data Ethics Policy, as well as internal policies and standard operating procedures.
Explore our progress on our environment, social and governance priorities in our latest Annual Report.
Responsible supply chain management
Ambu's purchasing decisions have a major environmental, social and economic impact ‒ not only on ourselves and our direct suppliers, but also on the entire supply chain and the local communities that we source from all over the world.
Close collaboration with our suppliers is therefore essential to fostering the sustainability of our end-to-end supply chain.
Our Responsible Supplier Program, coupled with our Code of Conduct for Business Partners, has been developed to ensure that our suppliers not only address quality and cost requirements, but also a wide range of sustainability and integrity considerations. It revolves around five key areas for responsible business practices:
- Human Rights
- Labour standards
- Environment
- Energy and climate
- Anti-corruption
The program is included in the Ambu Compliance Management System (CMS) and contains a variety of methods designed to ensure a responsible supply chain, including a code of conduct for business partners, supplier self-assessments questionnaires, supplier audits, risk assessments and due diligence processes.
Supplier due diligence is conducted on an ongoing basis, with revision and repetition of the exercise every two to three years, based on the latest risk profile. New suppliers enter the program through the supplier onboarding processes.
Furthermore, we continuously monitor and adapt to new and upcoming regulations, such as:
- The EU Corporate Sustainability Due Diligence Directive (CSDDD)
- U.S. measures addressing supply chain compliance
- Multilateral economic sanctions in response to concerns about human rights and forced labour
The goal of all these activities is to reduce or eliminate human rights-related risk and ensure supply chain stability, while providing our customers with high quality products.
Furthermore, Ambu wants to support suppliers who are committed to implementing responsible business practices. Therefore, if a potential issue is identified during the due diligence process, Ambu and the supplier will agree on and collaborate on the needed improvements, rather than simply terminating the collaboration with the supplier.
Conflict minerals
Ambu is committed to the responsible sourcing of conflict minerals in our supply chain, and to complying with applicable requirements.
To ensure this, Ambu carries out due diligence processes that include the reviewing of raw materials for potential content of conflict minerals used in our products. Where relevant, CMRT (Conflict Minerals Reporting Template) documentation is provided, and we issue product statements stating that our raw materials in specific products are not known to be sourced from conflict areas.
Ambitions and targets for responsible supply chain management
Work with and support suppliers that share our commitment to sustainability and responsible business practices.
We have a target of 98% signage of our Code of Conduct for Business Partners.
Explore our progress on our environment, social and governance priorities in our latest Annual Report.
