Success in bringing a medical device to market is a sum of great idea, good engineering, proper investment process, regulatory awareness, clinical research, good timing, good research strategy, proper manufacturing.
Europe is an attractive place to start medical device development – convenient regulatory environment, cost-efficient clinical investigations, experienced and well-educated physicians and patients, mature health care system, transparent regulatory policy, short time to market, springboard to access emerging markets.
KCRI has broad experience, excellent resources and local knowledge required to bring a new medical device from an idea stage to a regulatory approval.
Although we are focused on clinical research phase, we also actively support:
- device development by regulatory guidance (CE submission, but also US regulatory processes – 510(k) and PMA)
- tailored and product-oriented study design
- expedited site set up and patient enrollment through close cooperation with site networks
- design and accomplishment of regulatory strategic goals
Since 2004 KCRI has participated in the successful development of a number of innovative technologies especially for cardiovascular applications.
We will gladly help to bring your device to market too.