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.
