Technical Files and Design Dossiers for medical devices are required to be maintained to the industry’s current, evolving standards. Although most files are up to date when products are first released, failure to maintain the technical documentation as industry standards evolve can result in the loss of a product’s CE Mark. The CE Mark must be affixed to medical devices in order to trade them freely within the European Economic Area (EEA). The CE Mark indicates that the product has been assessed before being placed on the market and meets European Union safety, health and environmental protection requirements. The loss of a product’s CE Mark translates to the loss of sales in approximately one third of the global medical device marketplace, and could substantially undermine revenues.
In February 2005, a $6 billion medical device company based in North America with global manufacturing facilities hired GCI to review their Technical Files and Design Dossiers for compliance to the European Union’s MDD, in support of their CE Mark. The company did indeed have technical documentation, but many of the products had been released years earlier, and in some cases the technical documentation had not been maintained current with evolving requirements. This common situation put their ability to market and sell product in the EU in jeopardy.
Referencing the MDD, the client’s Standard Operating Procedures, our benchmarked industry best practices, and key requirements of the pertinent standards (e.g., ISO 11137 for their sterilization validation, ISO 10993 for biocompatibility testing, ISO 14971 for risk management, etc.), GCI developed a template of requirements against which a gap analysis could be performed. We then trained an assembly line of young, tech-savvy engineers in the standards, regulations and template. The engineers set to mining the technical data, including seeking out test reports in electronic document repositories and in dusty desk drawers if necessary (remember these products were developed years ago), to demonstrate substantial compliance of legacy products to the template’s requirements. Gap analyses were completed quickly and consistently, due to our assembly line approach, where with each exposure, the subject matter experts developed knowledge and efficiency in their ability to read and interpret the documents against the requirements in the template. Senior engineers with operational and regulatory experience were on hand to answer questions and provide interpretation as needed. In addition to the detailed gap analysis, a compliance plan was delivered to the client showing how to remediate the gaps with both a minimal compliance and a robust compliance solution, which the client could select for implementation, depending on business and regulatory strategies for the given product families. Additionally, GCI’s engineers highlighted opportunities to leverage similar product data, and we drafted justifications for creative and compliant decisions, lifting much of the compliance burden. The final gap analysis and compliance plan were completed early and 20% under budget, with the balance of the funds returned to the client. The client was so impressed with the efficiency, accuracy and economy of our team, that they hired GCI to remediate the gaps according to the compliance plan. Using the same assembly line approach, we remediated gaps in process validation, design verification, labeling, specifications, and FMEAs, and compiled robust Technical Files and Design Dossiers to replace the ailing legacy versions. Remediation activities included updates to technical documentation and execution of verification and validation for designs and processes. GCI stands behind our work, so when the Notified Body returned to the client’s Headquarters for a surveillance audit, we were on site to respond to the auditors’ detailed technical questions. There were zero audit findings, and the client subsequently hired GCI to expand remediation services at seven different facilities worldwide.