Acceleration of Medical Device Development
Traditional development approach before the CE marking and product launch on the market.
Production and Marketing
In case of less complicated and low-risk devices, problem identification and device development along with testing, takes about 1 to 2 years. Moreover, another 1 to 2 years are required for product delivery to the EU market. Fortunately, the duration of these procedures can be shortened to 12-16 months through the Fast Track plan that we provide.
In general, the Fast Track process can be divided into several stages:
Gathering and analysis of relevant scientific literature on a medical product that is required for its Clinical Evaluation Report along with the draft of the Clinical Evaluation Report.
Conducting a conformity assessment of the medical device following the Ukrainian regulatory requirements and the product launch on the market.
Gathering follow-ups through the post-market surveillance and extension of the Clinical Evaluation Report utilizing the clinical experience data.
Moreover, Fast Track has undeniable benefits, including the following:
No need to obtain special clinical study approvals
No requirement for ethics committees reconciliations
No necessity of adherence to special patient recruitment procedures or insurance issues
To get further information on Fast Track CRO, do not hesitate to contact us!