TUESDAY JUNE-24-2014

01:00 PM | 02:30 PM EDT DURATION: 90 MINUTES

Live webinar on "Medical Devices: EU Directives, Guidance Documents, CE Marking Process and I ! Certi"ication Programs"
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Detailed 'genda o" t$e

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Definition: Medical Device or Personal Protective Equipment. Overview of the Global Medical Device Industry Standard Active Implanted In Vitro Diagnostic Combination Products; Drug or Biologic + Device- Interface with Other Directives and How Its Treated from a Regulatory Perspective An Overview of the Medical Device Directives. Development, aims, implementation and update of the Medical Device Directives Implication of an EU Directive vs. Regulation Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination Products Update on the additional guidance documents relating to the directives Essential Requirements Classification of MD's and Process Implications Conformity Assessment Technical File Relationship to EU Clinical Trial Directive Guidance Documents. Medical Device Directive Annexes. Compliance Requirements by Type Full Quality Assurance System Declaration of Conformity Safety. Medical Device Vigilance System Manufacturer's Requirements GMP GCP CE Marking ISO Certification Clinical Trials Labeling ISO Standard Certification. Overall process; Management Commitment & Involvement Role of Notified Bodies

Relationship to CE Marking ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards ISO-14155 Medical Device Clinical Investigations. Part I- Clinical Studies Part II- Clinical Investigations Linkage to EU Clinical Trial Directive; What Does & Doesn't Apply Compare & Contrast EU & FDA Procedures and Requirements. Process Similarities & Differences Implications for Industry Company Management Process Changes Management Team Effectiveness Regulatory Approval and Liaison with Regulators. EU Co-Decision Procedure Committees, Working Parties Relevant for Medical Devices When and How to Influence Regulators Do's and Don'ts of Regulatory Involvement Individual Company Involvement vs. Trade Association Learning !b+ectives U2$ %$+2,e(i$ $# (his %$&"se !((e 'ees wi,, h!-e ! (h$"$&)h / $w,e')e $# (he "e*&i"e+e (s #$" 'e-e,$2i ) ! ' +!"/e(i ) Me'i%!, De-i%es !%"$ss (he E&"$2e! U i$ 3 The Di"e%(i-es !"e %$+2,e9 ! ' (he "e*&i"e+e (s 'i##e" s$+ewh!( b5 Me+be" S(!(e3 The %$ (e ( $# (his %$&"se is 'esi) e' ($ si+2,i#5 (he & 'e"s(! 'i ) $# !,, "e*&i"e+e (s ! ' ($ 2"$-i'e !((e 'ees wi(h (he ,!(es( i #$"+!(i$ "e)!"'i ) i (e"2"e(!(i$ ! ' e #$"%e+e ( $# (hese "e)&,!(i$ s3 #$o #ill ,ene"it This w$"/sh$2 wi,, be $# )"e!( -!,&e ($ Me'i%!, De-i%e 2"$#essi$ !,s ! ' (h$se i -$,-e' i (he "e)is("!(i$ $# Me'i%!, De-i%es !%"$ss (he EU3 I( is 2"i+!"i,5 'esi) e' ($ be e#i( (he #$,,$wi ) 'is%i2,i es: 0,i i%!, "ese!"%h ! ' +e'i%!, $2e"!(i$ s P"$:e%( M! !)e"s P"$'&%( De-e,$2+e ( 2e"s$ M! &#!%(&"i ) 2e"s$ e, e,

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Live
One Dial In - One $189Attendee One Dial In Unlimited attendance (To be arranged in a $249Conference room/ eeting room! "ote # Onl$ One Dial In Allo%ed&

A,, 2e"s$ e, wh$ ee' ($ & 'e"s(! ' (he 2"$%e'&"es ! ' i+2!%( $# 2,!%i ) Me'i%!, De-i%es $ (he M!"/e( i (he EU <30 e92! 'e' EEA %$& ("ies= #ebinar Includes:
Q/A Session with the Expert to ask your question Handouts (PDF print only copy of PowerPoint slides) 90 Minutes Live Presentation Certificate of Attendance

Combo
Combo 1 (One Dial In - Unlimited $'29attendance ( On Demand )ecorded *e++ion& Combo 2 (One Dial In - Unlimited $'49 attendance ( Training CD&

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For any assistance contact us at support@compliance2go.com or call us at 877.782.4696 Or Visit us:- $tt*s:--com*liance.go/com-*roduct-0

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Recorded
On Demand ( 9, Da$+ of online $289*treaming acce++ a-ailable after t.e li-e +e++ion & /la$ 0ac1 Unlimited 2ie%+ ( )ecorded file $'19 a-ailable for do%nload after t.e li-e +e++ion & 4et Training CD $'39

Multiple Location
$1,9 5lti6le location 9 - U6 to 3 Dial in $499 allo%ed