Medical Devices

Medical Devices

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.

Clinical Services

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.

• Provide customized clinical trial protocol and randomization plan for medical devices studies.
• Select an appropriate site with in-depth experience, staff, facilities and patients to conduct the clinical trial successfully.
• Calculate sample size and recruit patients according to the strict standard based on the characteristics of candidate medical device.
• Provide assay validation and methods comparison according to the regulation of CAP, CLIA, ISO, FDA, EMA, or analytical component of PMA, 510(k) (Class I, II, III and de novo), CE mark, LDT, IDE applications.
• Provide clinical trials spanning from pilot study through post-market study:

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.

• Provide close safety monitoring and careful program observation to ensure the accuracy and consistency of data collected during the clinical trial and keep the safety of patients.
• Provide data analysis and data management service including:

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.

• Provide clinical evaluation reports (CERs).

Our Highlights

• The state-of-the-art device testing facilities assure best-in-class safety and efficacy testing.
• CD BioSciences provides tailored programs to meet unique testing requirements of each client.
• We guarantee cost-effective, complete and concise reports.

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.