TUV Rheinland is running a course entitled 'Are You Ready for the Changes to the Medical Device Directive?', which aids compliance with Directive 2007/47/EC.
TUV Rheinland will explain the changes to Directive 2007/47/EC, which amends sections of the Medical Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the Biocidal Product Directive (98/8/EC).
The seminar will summarise the new directive and its effect on all previously classified medical devices.
The agenda will also include the Medical Device Directive's: new definitions, extended scope, classification changes, essential-requirement changes; required clinical-data evaluation; process for conformity assessment; and recommendations for implementation.
The TUV Rheinland seminars will take place on the following dates and locations: 26 January in Waltham, Massachusetts; 2 February in San Francisco, California; 3 February in Irvine, California; 2 March in Shoreview, Minnesota; and 4 March in Tampa Bay, Florida.
It is suitable for those involved in regulatory affairs and compliance, research and development, imports/exports, sales and product marketing.
