Audvanta: Clarity. Confidence. Compliance.
Cut through regulatory complexity with clear, actionable guidance
Be audit-ready; our independent evaluations ensure you’re always prepared
We help you align with evolving frameworks without compromise.
Audvanta was established to support medical device manufacturers in preparing for regulatory evaluations with independence and clarity. Its founder, Ardalan Khosravi, is a certified lead auditor with over 25 years of global experience auditing for Notified Bodies and Auditing Organizations such as BSI, SGS, QS Zürich AG and GMED. His background also includes five years of hands-on experience in design, development and manufacturing of medical devices. Audvanta is committed to impartial review, objective evaluations and aligning with international compliance frameworks without engaging in implementation or consulting services.
Our services are structured to enhance audit preparedness and regulatory alignment while maintaining the independence required of an experienced evaluator. We do not provide implementation or consulting, but rather structured review and awareness-focused engagement.
The FDA’s final rule transitions the current Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) on 2 February 2026. Until that date manufacturers must continue complying with 21 CFR Part 820 (the existing QSR). The QMSR aligns U.S. quality system requirements more closely with ISO 13485:2016. Audvanta does not provide consulting or implementation services but offers independent evaluations and awareness-focused discussions to help you stay informed and audit-ready during the transition.”