Archives: Case Studies

CE Mark: 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 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.

Production and Process Control

Background

A Fortune 500 biotechnology company faced ongoing challenges during campaign changeovers due to missing parts critical to equipment assembly. These deficiencies frequently led to costly, last-minute part fabrication and heightened the risk of production delays and revenue loss. Each near-miss placed increasing stress on operations management and threatened overall manufacturing continuity.

Further complicating the issue, equipment setup was based solely on Process and Instrumentation Diagrams (P&IDs) and relied heavily on employee memory, making the process inconsistent and prone to human error.

Regulatory Compliance Associates® Inc. (RCA) was engaged to identify and implement a comprehensive solution. During the initial assessment, RCA determined that the existing process lacked proper documentation and did not meet current Good Manufacturing Practice (cGMP) requirements. The solution not only needed to resolve the missing parts issue, but also establish robust GMP-compliant documentation to ensure the process was repeatable, controlled, and inspection-ready.

RCA Approach

Following a thorough investigation, RCA developed and implemented a standardized process to eliminate the recurring issues. This solution included the creation of detailed build lists, standard operating procedures (SOPs) featuring embedded color photographs, and 3D exploded diagrams for each equipment setup. To improve traceability and ease of identification, all equipment components were laser-etched with part numbers aligned with the supporting documentation. Campaign-specific sealed containers were introduced to organize and secure the necessary parts in advance of changeovers. RCA also conducted extensive employee training and established continuous improvement metrics to monitor performance and ensure long-term program sustainability.

Result

As a result of RCA’s solution, missing parts during equipment setup have been fully eliminated. The new documentation meets cGMP requirements and now serves as a key training resource, significantly reducing reliance on tribal knowledge. Campaign changeover times have been reduced by a minimum of two days—and up to six days in some cases—leading to a substantial annual cost savings of $4 million.