William Daunch & Associates, LLC (WD&A) is a specialty consulting practice devoted to accelerating the design, development, verification, validation, technology transfer, manufacturing, regulatory approvals and commercialization of medical devices and combination products.

WD&A specializes in gathering customer insights, then using rapid prototyping and design thinking to refine insights into value drivers, translating value drivers into high quality VOC-based design inputs, then translating design inputs into measurable and quantifiable design outputs that lead to fit-for-purpose medical products.

WD&A manages and supports fundamental and applied R&D projects as well as new opportunity identification and product development aligned with your strategic pipeline and portfolio planning process. WD&A has additional expertise in new process development and scale-up, product and process modeling and simulation, pilot and pivotal preclinical in-vitro and in-vivo investigations, as well as evidence generation studies, commercialization and manufacturing and regulatory support for 510(k) and PMA regulated medical devices.

WD&A taps an extensive professional network of Medical Device and Combination Device experts to support all stages of your product development process.

Company’s Keywords:

medical device manufacturing & scale up, medical device design & development, medical device regulatory submissions 510 & pma, medical device new product insights & value drivers

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