Impact in action
A quality mindset
Ensuring the highest standards of quality and safety in our products, while meeting the regulatory requirements, is crucial to our purpose of providing life-changing differences through hearing health.
Working with quality is vital for us to sustain the high standards and reliability of our products and to ensure the safety of our customers and users. We ensure that the Group complies with relevant regulations related to specific substances and defines quality management in quality policies for the Hearing Aids and Diagnostics business areas.
We furthermore mitigate risks associated with quality and safety by Biological Safety Evaluation and use ISO10993 as a guiding standard. We evaluate materials in skin contact in accordance with the standard and when necessary, we perform animal testing according to ISO10993-10 while evaluating whether chemical extraction and characterization is deemed sufficient instead. These tests are conducted by external partners.
To safeguard our ability to deliver the clearest communication to our customers and users, clinical validation and marketing processes ensure that we conduct responsible marketing all the way from headquarters to local markets.
Restricted list
We ensure that the Group complies with relevant regulations related to specific substances. All relevant substances, which are banned or restricted, are listed in the restricted list.
The restricted list is based on the following regulations:
- Restriction of Hazardous Substances (ROHS)
- Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) directive
- Toys directive
As far as conflict minerals are concerned, which are subject to the requirements of Dodd-Frank Section 1502 or Regulation (EU)2017/821, suppliers are requested to declare content.
On top of the mandatory legal requirements, we have imposed extra restrictions on our use of substances, e.g. a ban on the use of all phthalates and natural rubber latex.