Get help to test, certify and document any hearing solution to ensure market access.
We can contribute to shaping your market access strategy by offering pre-testing during the design phase and mapping out the scope of requirements and documentation levels. We guide you through the documentation and test process every step of the way.
Based in Denmark, home to some of the world's leading hearing aid companies, we have contributed to developing standards for hearing solutions for decades. We are proud to be among a select group of test houses with the facilities, expertise and accreditations to offer a broad spectrum of services tailored to support hearing product manufacturers in gaining global market access.
Reliability tests
Tensile, drop, mechanical shock and vibration, thermal shock (high/low temperatures and humidity), pressure, biocompatibility standards (ISO 10993), toxicological harmful chemicals, harmful substances such as phthalates and latex, wear testing, artificial earwax testing, sweat testing, battery compartment testing, dust testing (IP IEC 60529), and battery life testing.
Sound quality tests
Using SenseLab, a world-leading, widely recognised evaluation system with a trained listening panel and facilities meeting the highest standards.
Hearing aid battery testing
Primary and secondary batteries: IEC 60086-1, -2; EHIMA recommendations for Zinc-Air Hearing Aid Batteries. Adjacent management systems and quality management systems for medical device manufacturers, including requirements for documentation, traceability, risk management, process and product validation, helping to comply with industry and regulatory requirements.
Certification of services and compliance documentation
Medical Device Regulatory (MDR); FDA; EC; IECEE CB Scheme via FORCE Certification. To guide you through the extensive regulatory framework for market access, we have a specialised Approval Management Team ready to assist with coverage, definition, composition of approval documentation and project management to ensure that the enabling markings and declarations of conformity, as well as all other parts of the documentation basis, are in place.
Standards
Medical devices and audiology testing
Medical devices testing and approval
Ensure regulatory compliance and market access with accredited testing and approval services for medical devices, including EMC, safety and risk documentation. Expertise for manufacturers.
Ensuring market access for sustainable and safe medical devices
We strive to make innovation, development, test and launch of new medical devices and equipment easy and safe
Medical devices and audiology testing
Technical audiology testing of hearing aids and equipment
Accredited testing of hearing aids, audiological equipment and approval of hearing clinics with documented measurements and test reports.
Reach out to Compliance and product testing for more information.