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A Basic Guide to the Evaluation of Standards
| ISBN | |
| Verkaufspreis Inland (inkl. MwSt.) | 76.00€ |
| Verkaufspreis Ausland EU (inkl. MwSt.) | 76.00€ |
Medical device manufacturers apply a wide range of standards across their operations, Quality Management Systems and to products or technology. In the latter, a company typically uses numerous standards to demonstrate fulfilment of product specifications, conformity with European regulations or specified requirements (notably, design inputs). This author’s experience reveals a huge dearth of knowledge and awareness of the status of such standards and how they may be applied, how to evaluate a standard, and (perhaps most importantly) the evidence necessary to demonstrate conformity and limits conferred. The purpose of this document is to guide the selection and application of standards by a medical device manufacturer to demonstrate presumed conformity of a product. The document presents a high-level question and answer overview of voluntary technical standard status and use in the medical device sector. Commonly-asked questions are covered, plus a few not immediately obvious questions, to allow introduction and quick access to the subject.
Specification: 11 pages plus covers, in English, supplied by email as a PDF.
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| Verlag / Anschrift | aktualisiert am | Seitenaufrufe | |
|---|---|---|---|
| Global Regulatory Press | 25.03.2019 - 15:28 | 35 | |
| Units 317/318 Burford Business Centre, 11 Burford Road , E15 2ST London | |||
| Ansprechpartner | Marija Capek  | +44 (0)1305 264797 | |
