It is essential for medical device manufacturers who are facing big challenges in the highly competitive marketplace to make their products meet all regulatory and quality requirements before launch. There are huge multiple methodological and interpretative challenges during the evaluation process of medical devices, especially for high-risk and implantable devices. Whether it is an IVD (in vitro diagnostic) or a monitoring device such as a blood pressure machine, CD BioSciences' experts have extensive experience in assay validation and method comparison. CD BioSciences is committed to accelerating the process of bringing the clients' new medical devices to market.
The clinical trials are conducted to assess the safety and effective performance of the medical device. Whether to conduct clinical trials depends on the class of the medical device. Class III (high risk) and some Class II (intermediate risk) devices are required to conduct clinical trials. CD BioSciences will work closely with our clients to complete the clinical trials effectively.
1) Pilot study: Collect preliminary safety and device performance data in humans.
2) Feasibility study: Assess safety and efficacy of the device in patients.
3) Pivotal study: Confirm the clinical efficacy, safety and risk of medical device.
4) Post-market study: Monitor long-term effectiveness, safety and usage in the general population.
Handling of missing data, survival analysis, analysis of quality-of-life variables, interim analysis, and adjustments for multiplicity of primary and/or secondary endpoints or of hypotheses, sample size re-estimation, and meta-analysis, data management plan, data review and data transfers.
CD BioSciences is dedicated to applying all of our rich experience conducting pre- and post-market studies in your clinical trials services. You will work with our professional teams who could totally understand and have conquered the challenges you are faced with. If you are preparing to undertake clinical trials for your medical device candidate, please contact us without hesitation for further information about what we can do for your device development program.