Accordingly, key revision-controlled documents such as Design Inputs, Risk Analyses, and Design Outputs are updated as necessary over the lifetime of the product. The ready availability of these core documents as part of a Design History File (DHF) means that when product changes are needed, a repository of design information is available and needs only to be reviewed or modified. Recreating such analysis and documentation to enable a minor product or process change can slow down a company’s change control process.

Additionally, having ready access to comprehensive hazards and risk analysis allows more efficient and credible determination of required actions when investigating product issues encountered by customers. If an FDA investigator responding to reports of patient harm associated with a product discovers that there is not even a process in place by which the risk of harm could have been anticipated, red flags arise that there could be many other potentially harmful situations that also were not predicted. If the development and post-market surveillance processes are sound, product recalls or emergency field corrective actions may still be necessary, but the company will be less likely to face regulatory actions due to noncompliance concerns.


In summary, design development requires significant analysis and documentation to ensure that requirements are understood, risks are addressed, and that, ultimately, the product launched will be safe and effective. The small investment in additional front-end documentation can avoid embarrassing and costly program delays, save time and money in the long run, and reduce the risk of harm to patients.

This article was written by Larry Servi, Director of Product and Process Development for Regulatory Compliance Associates, Inc. in Kenosha, WI. Contact Larry at This email address is being protected from spambots. You need JavaScript enabled to view it. or visit http://info.hotims.com/34454-162.

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