Product Development Process
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Background
A global manufacturer of pharmaceutical and medical devices needed to better integrate key risk indicators throughout the product lifecycle. FDA had noted issues with risk management among a list of FDA 483 observations. Additionally, standardization of the product development process (PDP) across multiple businesses and global locations was needed.
Challenge
RCA was requested to write new PDP procedures that would apply to both drug and device developments. These risks analysis procedures needed to be comprehensive yet flexible to be useful for design changes, line extensions, and OEM manufacturing.
Approach
Regulatory Compliance Associates® Inc. (RCA) provided medical device consultants who were experts in product development and quality system regulations. After identifying key risk indicators, the risk management framework included a portfolio of over ten new procedures and thirty templates. Operational risk & financial risk training was provided to client locations in the US and Europe.
Result
The new product development process was implemented and risk control was integrated in the following ways:
- Risk Management Planning is a part of Design & Development Planning
- Risk Analysis is an input to Verification and Validation test planning
- Risk Analysis via Process FMEA is required for OEM business
- Risk Reports and Risk Benefit Analysis are inputs to Final Design Review
- Risk Analysis and Reports reviewed periodically based on internally generated data and data received from customers (i.e., complaints)
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References
- FDA Code of Federal Regulations Title 21, Part 820.30, “Design Controls”, April 1, 2010.
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, “Design Control Guidance for Medical Device Manufacturers,” March 11, 1997.
- U.S. Department of Health and Human Services, Food and Drug Administration, “Guidance for Industry: Q9 Quality Risk Management,” June 2006.
- International Standards Organization, ISO Standard 14971: Medical devices—Application of risk management to medical devices. 2007.