Medical devices compliance
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Medical devices compliance
Information on European compliance for Medical devices
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Team NB FAQ on EN62304 standard for software lifecycle processes

Team NB FAQ on EN62304 standard for software lifecycle processes | Medical devices compliance | Scoop.it
In this respect the FAQ document provides that “[The] [medical devices directives, "MDD"] does not cover the overall service provided. MDD only covers design, manufacturing and regulatory post market activities of the medical devices.
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January & February 2013 Newsletter - European Public Health Alliance

January & February 2013 Newsletter - European Public Health Alliance | Medical devices compliance | Scoop.it
January & February 2013 Newsletter
European Public Health Alliance
The Irish presidency has also stated its commitment to make progress both on the clinical trials and medical devices directives.
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EU Data protection developments: privacy by design – literally, may ...

EU Data protection developments: privacy by design – literally, may ... | Medical devices compliance | Scoop.it
Medical devices companies are used to the design requirements in the medical devices directives, their harmonised standards and a bunch of other statutes, like WEEE, EUP, RoHs, REACH, Batteries and the rest.
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Proposed Directive on Network and Information Security – frequently asked ... - EU News

Proposed Directive on Network and Information Security – frequently asked ... - EU News | Medical devices compliance | Scoop.it
EU News
Proposed Directive on Network and Information Security – frequently asked ...
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Security of eHealth services also in the new directive?

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Product Safety and Market Surveillance Package 2013 - Questions and answers - EU News

Product Safety and Market Surveillance Package 2013 - Questions and answers - EU News | Medical devices compliance | Scoop.it
EU News
Product Safety and Market Surveillance Package 2013 - Questions and answers
EU News
What is covered by the market surveillance legislation and RAPEX?
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with special rules for SME's...

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New advertising law for some medical devices in France

New French law regulates advertisements of certain high-risk medical devices and IVDs. More information on European medical device regulations available from Emergo Group.
Olivier Marchesini's insight:

Some complications whith stand alone software with inbedded comments and support?

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