A Literature Search Protocol defines the process for locating and evaluating relevant clinical and scientific publications concerning a medical device or comparable devices.

The identified clinical evidence, published studies, safety data, and performance outcomes are compiled in a Literature Search Report to support clinical evaluation activities and regulatory submissions.

We prepare systematic Literature Search Protocols and comprehensive Literature Search Reports to identify and assess relevant scientific and clinical evidence related to your medical device or equivalent devices.

Supports the demonstration of safety, clinical performance, and regulatory compliance through published literature and clinical data.

Demonstration of equivalence is the process of showing that a medical device is clinically, technically, and biologically equivalent to an already marketed product with accessible clinical data.

Where appropriate, this strategy may support regulatory approval by using existing clinical evidence.

We support equivalence assessments by comparing your device with legally marketed predicate devices across clinical, technical, and biological characteristics.

A structured equivalence assessment helps strengthen clinical evidence and supports regulatory submissions where applicable.

A Clinical Evaluation Report (CER) is a comprehensive assessment of clinical data demonstrating the safety, clinical performance, and benefit-risk profile of a medical device.

To demonstrate conformity with relevant regulatory criteria, the CER brings together post-market data, equivalence analysis, clinical evidence, and literature review findings.

We prepare complete Clinical Evaluation Reports that include clinical evidence, literature review findings, equivalence analysis, and post-market data to establish the safety and clinical performance of your medical device.

Structured documentation to support regulatory submissions and facilitate smoother approval processes.

Clinical evaluation is an ongoing process that should be updated throughout the device lifecycle based on new clinical evidence, post-market surveillance data, vigilance information, complaints, and significant product changes.

Our update support examines newly available clinical data, published literature, post-market information, complaint trends, vigilance data, and product changes to determine whether updates to the clinical evaluation documentation are required.

We review new data, monitor relevant clinical and safety information, and revise clinical evaluation documentation as necessary.

Helping keep clinical data current, scientifically supported, and aligned with applicable regulatory criteria for ongoing compliance and market access.