Download Design Controls For The Medical Device.Industry by Marie B. Teixeira PDF

By Marie B. Teixeira

Layout Controls for the clinical machine offers real-world examples, options, and templates for the implementation of powerful layout keep an eye on courses that meet present ISO 9000 and FDA QSR criteria and laws. It additionally bargains product improvement versions for the construction of secure, sturdy, and comparatively cheap clinical units and structures. The ebook information methods used by major businesses to effectively meet FDA and end-user specifications, manufacture top of the range items, and increase and generate revenue. It offers blueprints for the applying, overview, and refinement of caliber coverage and function practices, from product release via engineering and meeting.

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Different indications may result in different functional as well as product requirements. Suppose we say that our wound dressing should be indicated for use on chronic wounds. That’s a beginning, but should there be more? Will we be marketing a product that is indicated for all chronic wounds? Will the product be indicated for leg ulcers or for bedsores, or for both? What about chronic wounds that are infected? Certainly while we’re defining the indications for use, we might as well add the contraindications that are known.

Don’t forget that these are inputs. They should be based on data that is relatively concrete. ” If you did, it could set in motion a series of events that will ensure a product development that will fall short of its goals and perhaps even fail completely. A word of caution, although it should be apparent to everyone: This section of the PPS defines the indications for use, not the claims for the product. The definition of the claims comes in a later section. ” It tells the regulatory people, early in the development process, that they will have to prepare the submission documentation, but only if this new indication is written into the PPS.

Do the intended users require special packaging for ease of opening? Does the product design require specific packaging to ensure stability? A statement on the clinical and technical requirements. What is the product intended to treat or manage? How is the product envisioned to provide the treatment or management? How does it differ from other similar products? How is it the same? What should the product cost? What does it need to cost? Will it be reimbursed? Once this concept document is completed, and approved to move forward as an “official” development project, then a design team, composed of personnel representing different disciplines, should be assembled to prepare the product performance specification (PPS).

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