Case Study: Bond Digital Health achieves ISO 13485 and IEC 62304 compliance with Qualio

How Qualio empowered Bond Digital Health with an SaMD QMS from scratch

Bond Digital Health, a Cardiff-based medical software company, needed to build an SaMD quality management system from scratch while preparing its Transform SaaS platform for market. With compliance needs spanning ISO 13485, IEC 62304, GDPR, and HIPAA, Quality Manager Phil Cooley wanted a faster way to establish documented, repeatable quality processes without the burden of manually creating a QMS.

Qualio provided the solution by giving Bond Digital Health an easy-to-use, cloud-based eQMS with core functions like document control, training, quality events, suppliers, approvals, reviews, and version control. Qualio’s remote implementation helped the team get up and running in months, improved audit readiness through a single source of truth, and supported Bond in breezing through audits and achieving ISO 13485 and IEC 62304 accreditation.

Bond Digital Health

Phil Cooley

Quality Manager