Your success is our goal and our biggest reward
Consulting
Medical devices and IVD product development
Molecular assays design, reagents formulation, guard-band studies
Design transfer from R&D to manufacturing to field support and training organizations
Reagent manufacturing process, incoming raw materials specifications, QC methods, final release testing methodologies and specifications setting
Design for Quality and Manufacturability concepts
Verification and validation studies
Analytical/non-clinical reports and data line listings for FDA submissions, EU technical files
Education
R&D organizational setup and best practices
Application and compliance with FDA, EU and China regulations on medical devices/IVD devices
Interactions with international notified bodies (FDA, BSI, Health Canada, NMPA, MHWL), supranational organization (WHO) and NGOs (Global Fund, Gates Foundation)
Traditional V&V waterfall vs. agile product development methodologies
Cross-functional team setup, dynamics and conflict resolution
International, cross-cultural team dynamics
Services
Real-time support with:
FDA deficiency letter responses
Audits by notified bodies*
Supplier/vendor audits – ISO 13485, 21 CFR 820 compliance
Product field performance challenges, customer complaint investigation and resolution
*established clients only
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