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Compile a CE Marking Technical File 2018

Tuesday, October 29, 2019, 9:00 AM - 10:30 AM


Description:
Why you should attend
• Introductions and overview of the EU Directives
• Identify the EU Directives and standards applicable to your product
• Comply with the implementation details and requirements of the EU MDR & IVDR
• Design a new product, or evaluate an existing product, for conformity with these Directives and standards
• Conduct and document a detailed Hazard Identification and Risk Assessment of your product
• Complete the necessary Technical File and documentation required to meet EU legal requirements

Description:
Why you should attend
• Introductions and overview of the EU Directives
• Identify the EU Directives and standards applicable to your product
• Comply with the implementation details and requirements of the EU MDR & IVDR
• Design a new product, or evaluate an existing product, for conformity with these Directives and standards
• Conduct and document a detailed Hazard Identification and Risk Assessment of your product
• Complete the necessary Technical File and documentation required to meet EU legal requirements
• Understand the relationship between CE Marking requirements
• Determine exactly which materials need to be compiled
• Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
• Evaluate and identify gaps or deficiencies in your documentation
• Compile your EU Technical File or Design Dossier, with internal peer review
• Determine applicable testing requirements and standards for your device
• Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary
• Review your proposed labeling and Instructions for Use
• Understand what CE marking is
• Explain CE marking to others
• Understand how to demonstrate compliance
• Create a Declaration of Conformity
• Prepare a Technical File and Design Dossier
• Identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers
• Avoid incomplete Technical Files which can result in unexpected delays or prevent market entry
• Know what is expected by Notified Bodies for technical file content during reviews and be better prepared
• An awareness of those global markets that recognize the use of STED
• An appreciation of the common pitfalls and mistakes within regulatory submissions
• Learn how the new MDR for Europe has a direct impact on the documentation going forward
• Learn how to plan for a gap assessment to transition an organization to compliance for your CER under Europe's Medical Device Regulation 2017/745
________________________________________


Who will benefit:
Personnel who want to know all aspects of the CE Mark, Technical File and Design Dossier and the impact from the new MDR for EU. Medical device professionals in areas of Quality and Regulatory Affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU.

Location: Zurich, Switzerland Date: November 29th & 30th, 2018 and Time: 9:00 AM to 5:00 PM
Venue: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland

Price:
Until October 20, Early Bird Price: $1,695.00 Price: $1,695.00 (Seminar Fee for One Delegate)
From October 21 to November 27, Regular Price: $1,895.00
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)

Sponsorship Program benefits for seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901864SEMINAR?seo
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

Cost: 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)
Phone: (800) 447-9407
Tickets: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901864SEMINAR?events.kare11-NOV-SEO-2018
Event url: www.globalcompliancepanel.com/control/globalseminars/~product_id=901864SEMINAR?events.kare11-NOV-SEO-2018

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Venue

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Hilton Zurich, CA 81520

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