After several years of successful use in Europe, and the anticipated successful closure of clinical trials in the USA, a cardiovascular device manufacturer was poised to begin marketing their product in the United States. Before launching in the US, the company had to successfully pass an FDA Pre-Approval Inspection (PAI) as part of their Market Approval for a Class III PMA product. According to the FDA, “The PAI is performed to assess a manufacturer’s ability to design and manufacture the PMA device in accordance with the conditions specified in the PMA application and the requirements of the Quality System (QS) regulation.” The PMA preapproval inspection assesses the firm’s systems, methods, and procedures for the specific PMA devices to ensure that the firm’s quality management system is effectively established (defined, documented, and implemented). All PMA preapproval inspections are conducted as Level 2 Comprehensive Inspections, covering all four major subsystems (Management Controls, Design Controls, Corrective and Preventive Action (CAPA), and Production and Process Controls (P&PC)), as explained in the QSIT Guide. Refer to Part III of CP 7382.845, “Inspection of Medical Device Manufacturers,” for further guidance on Level 2 inspections. Successful completion of this major milestone was all that stood in the way of a successful US product launch and the realization of the shareholders’ financial goals.
The company’s goal was to prevent diversion of internal resources who were charged with maintaining a full pipeline of new product offerings, to prepare for the PAI. Therefore, GCI was contacted to assess and remediate three of the most critical and exposed areas of the quality system. The client and GCI determined the best approach was to provide three separate “balanced teams” for the remediation: each team consisted of several “roll up our sleeves” junior-level engineers who were the “do-ers,” and one senior-level “team lead” engineer to provide technical support, anticipate questions, and ensure consistent, high-quality output of his team’s deliverables.
GCI’s teams are very collaborative with the client, and as such, the team incorporated the feedback from the client’s leadership into deliverables before approval. Opportunities to group and leverage similar processes were identified, further enhancing the efficiency of the project. After on-time completion, GCI’s team leaders presented the final system and its interconnectivity with the client’s existing quality system to the senior leadership before working with Documentation Services for change requests and final approvals.
Final deliverables included standard operating procedures, validated processes and test methods, updated CAPA and Design History Files, updated supplier quality files, and a robust suite of documents to fill the gaps in quality records that could stand up to the toughest audit.
Following this effort, a subsequent PAI by FDA resulted in zero observations, enabling the client to successfully launch the product in the US market. Shortly thereafter, the company was sought after by a fortune 100 manufacturer, and had the foundation to negotiate a most appealing acquisition deal.