Challenge
An early-stage diagnostic company needed a fully documented Quality Management System compliant with ISO 13485 within 9 months, with no prior regulatory infrastructure and a team of four.
Approach
Built the QMS architecture from the ground up as an internal team member: document hierarchy, SOPs, risk management framework, and internal audit system. Co-prepared the team for the external audit and guided them through the review process.
Outcome
Full ISO 13485 certification achieved within the target timeline. The QMS has since served as the foundation for the company’s ongoing regulatory development.
Skills & Methods
ISO 13485QMS ArchitectureSOP DevelopmentRisk ManagementInternal AuditRegulatory Build-out
Related Service
Regulatory Affairs →A similar challenge in your organisation?
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