Karina Birilo
Karina Birilo is a Business Development Specialist at Cognidox, where she helps medical device, pharma, and biotech companies modernise their quality systems with a lean and affordable electronic Quality Management System (eQMS). Passionate about the intersection of technology and healthcare, Karina specialises in guiding teams through the challenges of ISO 13485, ISO 9001, FDA 21 CFR Part 11, and Part 820 compliance. She works closely with clients to replace inefficient paper-based systems and accelerate their digital quality journey—empowering them to scale confidently and bring life-changing products to market faster.
Every time a deviation is blamed on “human error,” an opportunity for real improvement is lost. In high-stakes...
4 min read
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