2018 - Compile a CE Marking Technical File 2018

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
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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. Employees and personnel who will benefit include:
• All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of MDD/AIMDD/IVDD and compiling the documentation
• Senior Management
• Regulatory Affairs Managers and RA SME's
• QMS Compliance personnel
• Quality Managers
• Design, Development, Manufacturing and Marketing Managers
• Auditors
• Risk Management
• Regulatory Affairs professionals
• QA/QC professionals
• Project Managers
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Marketing & Sales Management
• Distributors/Authorized Representatives
• Legal Counsel
• Consultants
• CRO's
• RA Specialists
• Clinical Affairs/Clinical Operations personnel
• Project Leaders
Agenda:
Day 1 Schedule
Lecture 1:
Technical File/Design Dossier/CE Mark
• Introduction and Overview
• Impact of the new MDR
• Directive 90/385/EEC covering active implantable medical devices
• Directive 93/42/EEC covering medical devices
• Directive 98/79/EEC covering in vitro diagnostic medical devices
• Introduction to the "Players:" The Medical Device Manufacturer, Competent Authority, Notified Body and the Authorized Representative
• Identify applicable legislation and requirements
• Confirm Medical Device Status and Class
• Identify and Meet Essential Requirements
• Technical Documentation
• Identify the appropriate route to conformity
• Assess for conformity
• Create and compile a Technical File and Design Dossier
• Declare conformity and CE Marking/Declaration of Conformity
• The EU "New Approach" Directives, and manufacturer's responsibilities
• CE Assessment Process: Overview
• CE Assessment Process: Detailed Compliance
• Identification of applicable Directives
• Identification of applicable Standards
• EU standards and the "presumption of conformity"
• Preparation of Technical File and Design Dossier
• Product markings, instructions, labels, warnings and languages
• Declaration of Conformity and the CE Mark
Day 2 Schedule
Lecture 2:
Technical File/Design Dossier/CE Mark
• Confirm the technical documentation requirements as specified in the Directive
• Interpret the general requirements of the Directive using relevant and harmonized standards together with various European & GHTF guidance documents for specific products
• Define the process enabling the creation and maintenance of compliant technical files and design dossiers
• Explain the Notified Body certification process and level of response required to questions and nonconformities raised
• Technical File requirements for CE marking to the current Medical Device Directives and the key changes with the new MDR Clinical Evaluation
• Updated requirements for content
• Risk Assessment
• Not all reviews are the same
• Changes affecting Technical files in the new Medical Device Regulation
• How to incorporate the new EU requirements with existing STED format
• Structure, layout and contents of Technical File including MDR requirements
• Gap Assessment for Technical Files and Design Dossier
• Review Technical Files and Dossier Dossiers
• New MDR (Medical Device Regulations) and impact for In Vitro Diagnostics and Medical Devices
• References and Guidance
• Industry Trends
Lecture 3:
Consulting Case Study Practice
• Participants role play consulting with instructor on Technical File and Design Dossier examples
• Ensure continuing compliance throughout device lifecycle
Lecture 4:
Case Study Practice
• Practice on a project relevant to participants' organization
Best Practices and Trends
Lecture 5:
Interactive Exercises and Discussions
• Case studies
• Examples
• FAQ's
• Q&A
Questions and Summary
Recap of Day 2
Speaker:
David R. Dills
Global Regulatory Affairs & Compliance Consultant and President, NovaQual
David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities, by medical device manufacturers and consultancies, including a globally recognized CRO, and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters,483 observations, and customer generated compliance events. He prepares for and conducts QS and regulatory audits He is currently acting and interim President at NovaQual LLC.
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)
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