Time: May 17, 2018 at 9am to May 18, 2018 at 6pm
Location: Hilton Zurich Airport Hohenbuhlstrasse 10
Street: 8152 Opfikon-Glattbrugg
Website or Map: https://www.globalcompliancep…
Event Type: seminar
Organized By: John Robinson
Latest Activity: Mar 22
Course "The New EU Medical Device regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Regulation proposals of the European Commission Background
In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject. The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.
Why you should attend:
Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.
Price: $1,695.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*
Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*
Register now and save $200. (Early Bird)
Until April 10, Early Bird Price: $1,695.00 From April 11 to May 17, Regular Price: $1,895.00
Sponsorship Program benefits for “New EU Medical Device Regulation | Updated Regulation 2018” seminar
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