Auditdata’s Auditbase Software Is Now Certified as a Class IIb MDR Device

The Auditbase Software from Auditdata has achieved certification as a Class IIb  SaMD (Software as a Medical Device) according to the Medical Device Regulation (MDR). Class IIb MDR is the highest level of classification possible in the audiology software industry. These types of regulations help ensure safety, reliability, and efficacy in medical software development and deployment. 

Class IIb MDR offers third-party validation that Auditbase customers are receiving industry-leading assurance in quality and compliance across: 

• Clinical and cyber safety.
• Reliability, due to its tested end-to-end process.
• Efficacy, as the product does exactly what it’s supposed to do. 

“EU MDR, a well-known, highly respected, and coveted classification, provides clear and balanced rules and a regulatory framework that’s recognized internationally. This designation, which was introduced to increase clinical safety and unify access to the medical market for manufacturers, provides objective proof that Auditbase meets the highest industry standards,“ Bager continued. 

Class IIb denotes a medium-to-high risk device, due to the use in diagnosing conditions that may result in a surgical intervention , requiring more data and analysis to demonstrate a device’s performance and safety. As a result, the conformity assessment procedure typically takes longer and may involve additional experts, including clinicians. 

The audit for this software was completed by an impartial third party, The Certification Body of TÜV SÜD Product Service GmbH. 

About Auditdata
Auditdata transforms the way hearing care providers can manage and deliver services to people with hearing loss. With data-driven solutions and services catering to all touchpoints of the audiology customer journey, Auditdata helps you take a proactive approach to achieve excellence in the way you deliver patient care and run your audiology business.  

Established in 1992, Auditdata has more than 30 years of experience working specifically with retail and hospital audiology software and audiometry. Around the world, 3,500 clinics with 10,000+ users already use the company’s software daily to improve clinical performance.