Quality management
Development and manufacturing under relevant quality processes.
Quality & Regulatory
Quality, verification and regulatory scope by device and market.
From requirements to defined deliverables.
These are representative work streams. Project scope, documents and timelines must be confirmed individually.
Performance verification
Test claims and verification requirements depend on device and market.
Regulatory documentation
Requirements vary by analyte, product and intended market.
Responsibilities
Define design responsibilities, documentation and market authorizations.
Clear responsibilities improve project clarity.
Different products and markets may require different testing, authorizations and documentation.
Lead times, minimum order quantities, design responsibilities and verification plans are agreed project by project.