accelerating medical Device
development
traditional approach timeline before ce marking and launch on the market.
concept
Planning
- Product development planning
- Risk analysis
- Requiremets
- Prototyping
- Test method development
- Production process development
development
- Detailed design
- Prototypes and tests
- Production process development and validation
verification
- Design freeze
- Pilot manufacturing
pre-
production
- Clinical trials
- Technical file or Design dossier reparation and NB submission
production
and
marketing
- CE making
- Product launch
It should be possible for less complex and lower risk class devices to go from problem definition to device development and testing within 1-2 years and another 1-2 years for delivery to EU market, but in Ukraine validation phases can be shorten to 12-16 months thanks to FAST TRACK procedure we provide
In short Fast Track
can be divided into stages:
Gathering and analysis of the appropriate scientific literature
on medical product, necessary for its Clinical Evaluation
Report substantiation in the applicable therapeutic sphere.
Draft of the Clinical Evaluation
Report
Conducting a conformity assessment
of the medical device according
to the Ukrainian regulatory requirements.
Placing the device on the market
Gathering follow-ups within the post-market
surveillance, extension
of the Clinical Evaluation Report
with the data of clinical experience
It is worth mentioning that
Fast Track
has undeniable benefits such as:
Favorable timeline
no need to obtain special clinical study approvals, ethics committees reconciliations, to adhere to special patient recruitment procedures, insurance issues etc
budget
For more information on Fast Track CRO,please contact us!
CONTACT Us
33B, Shota Rustaveli str., Kyiv, 01033, Ukraine
Mon - Sat | 9am - 8pm
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