Biostatistical Service for Medical Devices

Biostatistical Service for Medical Devices

Medical devices is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, accessory, which is 1) recognized in the Official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3) intended to affect the structure, or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animal and which is not dependent upon being metabolized for the achievement of its primary intended purposes” – [U.S. Code, FD & C Act; 21 US Code 321 (h)].

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 methods comparison, which can be applied in R&D validation and statistical sections of regulatory.

Our Services

• Developing statistical analysis plan (SAP);
• Calculating sample size and power, 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;
• Conducting 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;

• Consulting on bias, confounding and effect modification in medical devices studies;
• Consulting on randomization plan for medical devices studies;
• Consulting on the selection of appropriate design and methods to demonstrate the performance of our client’s medical device.

We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you with timely and high-quality deliverables. At the same time, we guarantee cost-effective, complete and concise reports.

If you are unable to find the specific service you are looking for, please feel free to contact us.