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Regulated industries must be in compliance with the product development mandates of multiple agencies. This compliance should be seamlessly integrated into the procedures and processes used for product development, not added as extra effort activities. Most compliance requirements are simply based on industry "best practice".
Customer requirements form the foundation of a product development project. If requirements are managed properly, the development and validation phases of the product development lifecycle are much more straightforward. Combined with a compliant process, the result is fewer audit findings and much faster product approvals.
An advantage of an effective product development process is that the ability to accurately estimate project timelines is improved. Not only is work breakdown simplified but product rework due to misinterpretation of requirements is minimized.
The company was started to support companies in the Diagnostic, Medical Device and Life Science industries. Clients range from new start-ups to very large, mature organizations. All aspects of the product development life cycle are supported.
Specific support is offered in the following areas.
If you have questions or would like to discuss your needs--
Cell: (209) 585-7499
FAX: (209) 758-0586
Email: mail@wmhoover.com