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. 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
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Sponsorship Program benefits for seminar
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