case study

Clearing a Hurdle for CE Mark: The Clinical Evaluation

Devicor, the leading breast biopsy device manufacturer, engaged RCA to build a clinical evaluation process.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Clearing a Hurdle for CE Mark: The Clinical Evaluation

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’s expertise helped complete the submission, leading to the CE Markings and enabling continuity of existing products and expanded distribution of new product.

Solution

Devicor engaged Regulatory Compliance Associates® Inc. 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.

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’s expertise helped complete the submission, leading to the CE Markings and enabling continuity of existing products and expanded distribution of new product.

Solution

Devicor engaged Regulatory Compliance Associates® Inc. 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.

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