Conference Description:

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.

Overview:
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.

Location: Chicago, IL Date: June 27th & 28th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price:
Price: $1,495.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*
Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*
Sponsorship Program benefits for “New EU Medical Device Regulation | Updated Regulation 2018” seminar
For More Information- https://www.globalcompliancepanel.com/co ntrol/sponsorship
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