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TRL Assessment Tool
TRL Assessment Tool
A manufacturable
A functional version of
Analytical studies on Basic technological Basic technological version of the product
the product working on a
separate elements of the components integrated components integrated working on an Product in its final form
realistic environment Product in its final form
technology. Laboratory together to show that within realistic context environment which working in full mode
A Product that is manufactured able to draw conclusions under full commercial
based trials that show they work together. At under a fully controlled addresses all the under expected
on the technical and deployment.
the feasibility of the this point durability is environment in or operational conditions and periods.
operational capabilities
predictions. not yet important. outside the lab. requirements for the
of the product.
product.
Development of a pilot-
Demonstration plant is
scale testing plant or unit Successful
Laboratory experiments Process components are Integrated validation of constructed (1/10th of
(1/100th of commercial demonstration of the Commercial plant/unit
are designed to verify validated indivually and the process to produce commercial scale) and
scale) including continuous operation of set up and running for
An industrial process that the conceptual could be integrated in an small outputs or short operated in continuous
engineering-scale the pilot plant/unit full range of operating
process works as ad hoc manner at lab batches of the end mode, including working
equivalents of all the during a relevant time- conditions.
expected. scale. product. outside normal
operations that will be frame.
parameters.
required at scale.
Pre-clinical studies
including GLP (good
Proof of concept and
laboratory practice) Manufacturing process
safety of the device is Medical device final
animal safety & toxicity. Medical device validated. Pre-market
Initial proof of concept demonstrated in vitro, ex product design is
GMP manufacturing prototype demonstrated application submitted
demonstrated with a vivo or in vivo conditions validated. Final
process and quality in operational and approved for Medical device ready to
limited number of in (non-GMP, Good prototypes intended for
A medical device controls identifed. environment. Clinical medical device. Device be acquired by the
vitro & in vivo trials Manufacturing Practice). commercialization use
Classification of the testing and safety demostrated in real life clients and end users.
including the expected System components produced and tested.
device by appropiated demonstrated. Required conditions, support
device characteristics. integrated and tested When applicable,
regulatory body accreditation in progress. structure in place for
regarding preliminary accreditation completed.
established. technical problems.
efficiency and reliability.
Accreditation when
appropriate initiated.