Anis Rahman, MS
Software validation and quality system expert with 15+ years of experience guiding medical devices, in vitro diagnostics, and digital health technologies through high-stakes FDA and global regulatory decision points.
Anis Rahman brings deep expertise in FDA regulatory strategy, quality systems, and global market access across IVDs, medical devices, and emerging diagnostic technologies. He has advised executive teams on U.S. and international regulatory pathway strategy, evidence planning, QMS implementation, and health authority engagement; particularly for novel diagnostics and device platforms navigating evolving regulatory frameworks.
Areas of Focus / Expertise
- FDA regulatory pathway and classification strategy for IVDs and medical devices
- Premarket submissions (510(k), De Novo, PMA, EUA)
- Global regulatory strategy (EU IVDR/MDR and international submissions)
- Quality systems implementation and remediation (QSR, ISO 13485)
- Design controls, risk management, and inspection readiness
- Clinical performance studies and analytical validation strategy
- U.S. market entry strategy for international manufacturers
Selected Experience & Impact
Over the course of his career, Anis has led regulatory and quality strategy for diagnostic and device manufacturers, supporting successful FDA clearances and global approvals. He has built and remediated quality management systems, guided organizations through FDA inspections, and supported commercialization of innovative diagnostic platforms across U.S. and international markets.
Background & Credentials
Prior to FDA Partners, Anis held senior regulatory and quality leadership roles within the medical device and diagnostics industry, advising multinational and growth-stage companies on FDA compliance, global regulatory strategy, and operational readiness. He holds advanced training in regulatory affairs and quality systems and has focused his career on aligning innovation with disciplined regulatory execution.
Anis approaches regulatory strategy with a systems-oriented mindset, helping organizations integrate compliance, quality, and commercialization into cohesive and durable frameworks.