For medical devices manufacturers, we provide tailored services for medical devices development and marketing in Europe. Our team of specialists are qualified professionals with extensive clinical research experience and wide-ranging clinical expertise, including regulatory, project management, and medical writing.
PILOT (10-30 Subjects)
- Small study to collect preliminary safety & device performance data in humans
- Guides device modifications &/or future study design
TRADITIONAL FEASIBILITY (20-30 Subjects)
- Assess safety & efficacy of the near-final or final device design in patients
- Guides the design of the pivotal study
PIVOTAL (+100 Subjects)
- Large study to confirm clinical efficacy, safety & risks
- Statistically driven
POST-MARKET (+1000 Subjects)
- Monitor long term effectiveness, safety & usage in the general population
DID YOU KNOW?
Considering that by 26 May 2020, all manufacturers need to obtain or renew their CE certificate, clinical investigations may therefore also be required for medical devices included in class I and class IIa, and for class IIb devices that are not implantable. Also implants and high-risk devices, those based on technologies where there is little or no experience, and those that extend the intended purpose of an existing technology (i.e. a new clinical use) will require clinical investigation data.
For clients in the stage of considering CE marking that have not yet performed testing and/or clinical trials considering CE requirements, we design clinical investigations under the Good Clinical Practice for the medical device industry ISO 14155:2011.
We are fully operational to conduct clinical investigations for medical devices CE and non-CE marked.
Together, we bring your medical device to the European market, complying with international regulations and assuring product quality and safety.