Basic Regulatory Training for Design Engineering			Download | Print
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Design of medical devices is regulated by law in e.g. the US and the EU. This training course aims to give a basic understanding of what these requirements mean for engineers in design projects. Course Goal After completing the training, you will know the fundamentals of what safety standards need to be followed, what design procedures (planning, specification, implementation, review, testing, etc) should be used and what documentation needs to be in place. You will also learn where to find more information and how to complete applications such as a 510(k). Participants will also learn about finding information, and filling in applications such as a 510(k). Audience Engineers working on the design of medical devices.			Content Regulatory framework EU / US Medical Device Directive Quality System Regulation Intended use Device classification Risk management Design controls and document controls Harmonised standards / concensus standards Technical File / Design History File CE marking 510(k) application Documentation, especially of software

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* Prices subject to change. Prices apply in Sweden and are in Euro, excl. VAT.
Sthlm = Stockholm, Gbg = Gothenburg, Cph = Copenhagen, Mmo = Malmö, Lkpg = Linköping, Jkpg = Jönköping, Oslo in Norway, Vantaa in Finland, Twyford in the UK.

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