Background

Devicor, the leading breast biopsy device manufacturer, wanted an updated CE mark strategy 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.

Solution

Devicor engaged Regulatory Compliance Associates to build a clinical evaluation process to achieve CE Mark approval. 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 Mark registration 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.

 

To begin the Regulatory Compliance Associates^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.