CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives) - Impact of the MDR for Europe (NTZ)
09:00 - 17:00
CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives) - Impact of the MDR for Europe
*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***REGISTER TODAY!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
- Risk Management
- Regulatory Affairs professionals
- QA/QC professionals
- Project Managers
- Compliance Officer
- Compliance Specialist
- Clinical Affairs
- Marketing & Sales Management
- Distributors/Authorized Representatives
- Legal Counsel
- RA Specialists
- Clinical Affairs/Clinical Operations personnel
- Project Leaders
Day 1 Schedule
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
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
Consulting Case Study Practice
- Participants role play consulting with instructor on Technical File and Design Dossier examples
- Ensure continuing compliance throughout device lifecycle
Case Study Practice
- Practice on a project relevant to participants' organization
Interactive Exercises and Discussions
- Case studies
Questions and Summary Recap of Day 2
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.
He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing responses to AI's/deficiency letters, Supplements, Amendments, acting U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
Mr. Dills has a strong background in the interpretation and applicabilityofFDA regulations,including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activitiesfor the registration and approval process andworking with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies.
Directs and leads efforts for PM support and consultative services on behalf of manufacturers and subcontracted bythird-partyconsultancies and provides services involving all phases ofthe product development, submission, and commercialization process from premarketing to postmarketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; UDI compliance strategies; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO13485 registration and CEMark; andmulti-countryproduct registrations and licensing.
Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and clarity on regulatory requirements, prepares and/or reviews submissions [e.g., NDA, ANDA, 510(k), PMA, IDE, CTD/CMC and BLA], including design dossiers and technical files, and other applications for Asia Pacific, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective product; provide compliance engineering support; and lead efforts for GxP Strategic Compliance.
Mr. Dills manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; conducts MDSAP training; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.
He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance, Governance, Assessments and Agency Mock Inspections; assist companies during FDA and other regulatory authorities' inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company's goals and strategies.
Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conductspersuasive communication with regulatoryauthorities;executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance withregulationsin The Americas, EMEA and Asia Pacific.
He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.
Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals.
Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science andBiology.Heis aformer Chair and Co- Chair of ASQ's Section 1506 and associated with the BiomedicalDivision,RAPS,AdvaMed, PDA, ISPE, and other industry working groups.
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