Uncertain Times for Medical Devices - Regulatory and Clinical Advice

Although the economic downturn has put increased pressures on medical device companies to curtail spending and has limited the available sources of venture funding, there are opportunities to continue product development activities while avoiding significant capital expenditures. Given the lengthy approval process for many devices, it is prudent to continue to add value to the technology and demonstrate incremental progress toward premarket review and approval. To that end, there are numerous regulatory and clinical activities that may be undertaken that do not necessarily require large outlays of capital to complete. Even though the U.S. regulatory environment for devices is in the midst of potentially significant changes as FDA examines its policies and programs, taking steps to add a degree of clarity to your product development pathway may be helpful in attracting investments for your product.

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Automating Document Control Processes to Comply with FDA and ISO Requirements

The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.

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