Design History File Remediation
Just because a product is ready for launch does not mean that the documentation to support the development of the device is ready. Kapstone has been engaged by a number of clients to help ‘clean up’ the product documentation, most important of which is the Design History File, or Technical Dossier. We are experts at remediation activities in order to bring the documentation of the design and development process up-to-date and ready for commercialization.
Design Transfer
Transferring a product from the design and development stage over to commercialization involves a number of steps, which are critical to success. Unfortunately, some of these steps are often overlooked, or minimized, in the rush to get to market. Kapstone takes a measured approach, recognizing the business need to get to market and begin generating revenue while understanding that a solid documentation package will not only prevent uncomfortable audit situations down the road, but also add to product and enterprise value through mitigation of risk in the short term.
Product Manufacturing
Through our extensive supplier network, combined with in-house capabilities, Kapstone Manufacturing can handle the entire process from initial manufacturing through packaging, labeling and sterilization. We are technology agnostic, meaning that we will find the best technology platform to fit your unique needs - whether that is traditional machining, additive manufacturing, injection molding, or a host of other options.
Product Distribution
Kapstone can advise on distribution model selection, helping you identify a model that works for your capabilities, product, cost structure and target markets. Our decades of experience are leveraged for your benefit in order to help craft the best distribution strategy for your product.
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