Case Studies
CE Mark: Clinical Evaluation
Client
Breast Biopsy Device Manufacturer
Industry
Medical Device
Business Challenge
To build a clinical evaluation process to provide relevant information and develop abstracts
Background
Devicor, the leading breast biopsy device manufacturer, wanted CE markings to expand distribution with new products and provide continuity with legacy products obtained through a divestiture.
The Medical Device Directive requires a clinical evaluation to verify medical device clinical safety and performance.
RCA Approach
Devicor engaged RCA to build a clinical evaluation process. RCA identified clinical data by conducting literature searches based on key words and phrases, filtered through studies and data for relevant information and developed abstracts for incorporation with Devicor’s final submission.
Results
Besides crafting the plan, RCA was instrumental in data collection and analysis of clinical data, reviewing thousands of papers. This expertise helped Devicor complete the submission, leading to the CE Markings and enabling continuity of existing products and expanded distribution of new product. Based on this successful experience, Devicor will gladly look to RCA for future needs in clinical evaluations.
