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PMS vendor globally certified to ISO/IEC 42001 for AI management.
Years of adherence to ISO 27001, ISO 13485, and EU MDR standards.
EU AI Act enforcement deadline — Auditdata is already aligned.
Of AI outputs subject to human review under the certified framework.
AI-generated outputs require human review. No "AI on autopilot", every output is checked before it reaches your software or your patients.
The certified system explicitly covers protection of individuals' privacy and safety, GDPR compliance, and applicable legal and ethical requirements.
Every external AI tool we use goes through structured risk and impact assessment; identified, treated, and monitored, not reviewed once and forgotten.
The certification is subject to annual surveillance audits and a full recertification cycle every three years, so governance keeps pace with how fast AI evolves.
Controls aligned with the EU AI Act, ahead of the August 2026 enforcement deadline. Work with a vendor that's ahead of the regulatory timeline, not behind it.
AI governance is integrated into how Auditdata designs, builds, and maintains its products,not a separate policy document stored in a drawer.
Built on a decade of compliance
Auditdata didn't start from zero. The AI governance framework is built on management systems we've maintained for over a decade — including the most stringent standards for information security, medical device quality, and regulatory compliance.
Trust earned over a decade is now extended to AI. Auditdata is the first practice management software vendor globally to hold ISO 42001 certification — and when your hearing enterprise works with a certified vendor, it strengthens your own compliance posture too.
Every AI tool and process goes through structured risk and impact assessments before and during use.
AI outputs are reviewed by people. Transparency and accountability are built into the workflow.
GDPR-aligned, with explicit protection of individuals' privacy, safety, and applicable legal requirements.
Risks are identified, treated, and monitored, backed by annual surveillance audits and a 3-year recertification cycle.
Clinic owners & managers
Feel reassured that the company building the software for your hearing care network governs AI to an international standard. When group leadership or regulators ask about your vendors' AI governance, you have answers, backed by independent audit.
Heads of Audiology
The software audiologists rely on is developed and maintained under the strictest governance framework — requiring human oversight of AI outputs, privacy protection, and structured risk management. AI supports clinical work in a way that's proven to be governed, transparent, and accountable.
IT & Compliance
Third-party AI tools are risk-assessed. GDPR compliance is baked in. EU AI Act alignment means you're working with a vendor that's ahead of the regulatory timeline — so your own compliance posture is stronger the day you start working with us.
Operations Leaders
As AI evolves rapidly, Auditdata has a certified framework to adopt new AI capabilities responsibly across the organization. The AI used to develop, improve, and deliver your hearing care tools is governed from day one, not retrofitted later.
Both. Our certified management system covers every use of AI across Auditdata. The AI tools our developers use to write and review code, the AI that supports our operations and consulting services, and AI in internal processes. Governance is woven into how we operate, not just stamped onto our products.
Auditdata has implemented controls aligned with the EU AI Act ahead of its August 2026 enforcement deadline. While ISO 42001 and the EU AI Act are separate instruments, our certified framework materially overlaps with the Act's requirements — so clinics working with us have a partner who is already operating to the standard the regulation will enforce.
ISO 42001 is not a one-time effort. The certification is subject to annual surveillance audits and a full recertification cycle every three years, allowing governance to keep pace with how AI evolves.
ISO 42001 integrates with 10+ years of adherence to ISO 27001 (information security), ISO 13485 (medical device quality), and EU MDR (regulatory compliance). AI governance is the next logical step, and Auditdata is the first PMS vendor globally to hold this certification. See all certifications here.
Every AI-generated output used inside Auditdata requires human review before it's acted upon. Third-party AI tools are formally risk-assessed. Risks are identified, treated, and monitored, not reviewed once and forgotten. This isn't AI on autopilot; it's AI with accountability built in.