Welcome to the Guidance and Impact Tracking System (GAITS) Platform Portal

A secure, web-based project milestone and portfolio management platform to de-risk and accelerate healthcare innovations.

MaturityDisplay

Requirement

Preliminary BOM and Manufacturing-QMS Plan

A preliminary bill of materials (BOM) and plan for manufacturing as well as quality assurance. What will be done in-house, what will be outsourced and how will you ensure quality?
Quality in the production of medical devices is key and needs to be considered at the earliest product design point as possible
Identify all the intended parts and how they will be sourced and well as assembled. Follow industry guidelines for QMS planning.

CategoryFiltersPortlet

Resource Type
Regions/Markets

Note:

To access the Resources that describe each Deliverable, use the Sign-in button above to create an account and then click on the Deliverable or the Innovation Maturity Level to see all Deliverables at that level and click on the one of interest. 

MedTech

Classic electro/mechanical medical devices such as surgical instruments and imaging systems.

See Guidance >

Biomarker Diagnostics

Diagnostics that are based on chemical or biological biomarkers.

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Digital Medicine

Digital solutions such as Apps and AI enabled systems that improve health and/or wellness.

See Guidance >

IVD

Tests done on samples such as blood or tissue that have been taken from the human body.

See Guidance >

Therapeutics

Chemically synthesized pharmaceuticals and biopharmaceuticals that are manufactured from biological sources.

See Guidance >