Request for Quote for Provision of a Quality Management System ISO 13485 Gap Analysis Review
Tender ID: 531771
Tender Details
Tender Description
Metro North Hospital and Health Services (Metro North Health or MNH), through Hertson Biofabrication Institute (HBI), is considering accreditation to ISO13485 by 1st November 2024. As such, MNH is seeking offers from qualified and experienced suppliers to provide ISO 13485 implementation and compliance guidance on HBI and supporting clinical satellite manufacturing sites.
MNH’s objective is to obtain an assessment of the current level of compliance with a roadmap to achieve ISO13485 certification by 1st of November 2024 for HBI taking into consideration the specific manufacturing capabilities for the clinical programs, Cancer Care Services and CranioFacial Surgery.