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.

Please complete the form to access the case study.

*=Required

Clearing a Hurdle for CE Mark: The Clinical Evaluation

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.

RCA’s expertise helped complete the submission, leading to the CE Mark approvals 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 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.

 

About RCA

mdr consultingRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

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

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.

RCA’s expertise helped complete the submission, leading to the CE Mark approvals 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 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.

 

About RCA

mdr consultingRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

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

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue