We utilize Design Control as our construct to take your product from feasibility all the way through regulatory submission. We will work with your team to ensure that the entire development process is documented to support your product's claims.
Lawrence Analytics knows that building a Quality System that identifies and tests the critical component and device specifications is accomplished in the early stages of product development.
Like Quality Systems, Manufacturing considerations start in the Research and Development stages of product development. Lawrence Analytics focuses on technology transfer and designed for manufacturing elements as part of each development milestone.
Process development, manufacturing equipment, cassette design and user-considered elements are fundamental to delivering the highest quality, lowest cost product to your customers.
Lawrence Analytics will direct or support your regulatory goals including 510k and CE Mark documentation. We have experts that can quickly identify and assist you through the fastest route to verification and validation studies.
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