Case Study: Drop Bio Health achieves TGA & ISO compliance and launches WellBeing with Qualio

A bespoke quality system for a growing Australian wellness company

Drop Bio Health is an Australian at‑home health technology company delivering personalized wellness insights from fingerprick blood samples processed with Class IIa in vitro diagnostic kits at its UNSW laboratory. Facing a grey regulatory space that blended TGA essential principles and ISO 9001/13485/17025 requirements—and needing strong consumer and clinician trust—Drop Bio Health needed a scalable, adaptable quality system. The company chose Qualio’s cloud-based eQMS to manage Documents, Training, Events and Suppliers as the backbone of its compliance program.

With advice from Dr. Lee Walsh (Platypus MedTech Consulting), Drop Bio Health went live with Qualio in August 2022 and began a controlled roll‑out. The team migrated 85% of legacy documents and 100% of supplier records, now has 9 of 13 team members accessing the system, is deploying Qualio’s “Training Plans,” and gained full traceability and root‑cause regression analysis from a single source of truth. Qualio provided the “critical layer” of quality that delivered a “base level of compliance,” boosted “confidence in what we’re doing in quality,” fostered company‑wide ownership of SOPs, and enabled the launch of WellBeing Version 2 within a year.

Drop Bio Health

Phil Hayes-St Clair

Chief Executive Officer