We are still awaiting the final legal opinions for the proposed changes to European law. This will be essential for all manufacturers/distributors/importers selling medical devices into the European Union to have cover for product liability. The scope of such cover must include all 28 EU states. Should Clients have problems with such cover we are … Read more
The topic of software validation is one that continues to cause confusion, so we have developed a series of flowcharts to help clarify the requirements. These cover: * EN ISO 62304; 2006 medical device software – software life cycle processes * FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff Please … Read more
OBL Guidance to Clients This article is now obsolete and has been replaced by our article on Virtual Manufacturing, which has replaced OBL. Press here to be redirected. As you are probably aware there have been significant changes to the requirements of Own Brand Labelling [OBL] in relation to the MDD 93/42/EEC and IVDD 98/79/EC contained … Read more
The Notified Bodies around the world are preparing themselves for the new upcoming MDD regulations recast. The regulation was published on 26th September 2012 includes the new EU regulations on all medical devices. The final regulation is likely to be released in 2014. The changes would reflect: v The new EU regulation structure and system … Read more
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