The manufacture and sale of medical devices, be they intravenous catheters or operating tables, is a highly complex undertaking requiring a deft balancing of FDA regulatory concerns with ambitious output goals. The range of topics that could be discussed regarding the inherent challenge in successfully reconciling these competing interests is vast, to say the least.
Despite every effort to negotiate this challenge in-house, device makers often face circumstances that necessitate the introduction of more specialized regulatory compliance expertise and medical industry knowledge.
Supply Chain Management, Raw Materials Validation, and Production
A common source of irritation for management is the constant struggle to efficiently integrate the acquisition, sampling and validation of raw materials with the time sensitive needs of production. Due to the complex interplay of complicating factors, it can sometimes be difficult to address recurring issues or even to proactively identify areas for improvement. In other words, sometimes you can’t see the forest for the trees.
Bureaucratic and institutional inertia, fear of FDA non-compliance and inadequate or inefficient communication between supply chain managers, QA/QC departments and production heads can all combine to prevent and slow the implementation of Current Good Manufacturing Practices (cGMPs). It is in these instances that medical device consulting can be of significant value.
Compliance experts can offer appropriate solutions that don’t needlessly increase legal and regulatory liabilities to attain better results. This may involve reevaluating SOPs and related documentation, analyzing supply procurement practices and validation processes or even offering pertinent training courses to empower key staff with the legal and federal regulatory knowledge necessary to confront future challenges.
Achieving Balance For Compliance and ROIs
The ultimate rewards for attaining the ideal balance between production goals and regulatory demands can be summarized as follows: a greater return on investment and successful audits. These rewards are often best achieved when neutral, outside experts help you institute best practices and corrective actions in a cohesive manner across corporate departments.
GxP-CC, international compliance experts for the medical device industry, provides proven strategies to companies needing help in meeting regulatory US and European government regulations. Contact them today to discuss your needs.