2-day In-person Seminar

Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)

August 1st & 2nd, 2018

Time: 9:00 AM to 5:00 PM

Zurich, Switzerland

Venue: Hilton Zurich Airport

Director : David R. Dills

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,895.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $5,685.00
      $9,475.00 You Save: $3,790.00 (40%)*

  Register for 10 attendees   Price: $10,422.00
      $18,950.00 You Save: $8,528.00 (45%)*
Course "Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Why you should attend

  • Introduction to MEDDEV 2.7.1, Revision 4 (2016)
  • This revised MEDDEV is generated within a context of increased scrutiny on the Notified Bodies (NB) by the Joint Assessments from the Competent Authorities, which has led to an increase in the level of review the NB exercise over clinical evaluations
  • Frequency for updating the CER is also much more prescriptive now and you must define and justify the frequency, based on "significant risk" of the device, as well as how "well-established"
  • One of the largest changes in this revision, the demonstration of "equivalence" is much harder now
  • Revision will lead to more clinical investigations, probably of larger size, and Notified Bodies will be looking more closely at how all the essential requirements are met, including those regarding usability
  • Manufacturers should start discussing with their Notified Bodies how they will start implementing these new requirements, and start performing their gap assessments and resource needs-assessments now
  • General considerations on updating the clinical evaluation
  • How is a clinical evaluation performed?
  • Appraisal of pertinent data
  • The role of the Notified Body in the assessment of clinical evaluation reports and key changes in 2016
  • Implement risk evaluation pre/post review
  • Establish design and intended use equivalence with competitor and preexisting designs
  • Identify data available from the clinical literature
  • Supply and prepare documentation relating to clinical investigations that meets Notified Body requirements (if clinical investigation was deemed necessary and completed)
  • Demonstrate that there is sufficient clinical data to meet the safety and performance requirements of the device
  • Identify residual clinical risks and determine whether post-market clinical follow-up is required
  • Maintain and update clinical evaluation documentation throughout post-market product lifecycle
  • The initial creation of a CER can be a painstakingly long process, and for smaller manufacturers, can prove quite burdensome - learn how to complete a literature review report which is a comprehensive analysis of available pre- and post-market clinical data relevant to the intended use of the device and includes clinical performance and safety data
  • Learn how the new MDR for Europe has a direct impact on the CER going forward
  • Why CERs need to be reassessed under the new MDR
  • 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 CER process and MEDDEV 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 MEDDEV 2.7.1, Revision 4
  • Senior Management
  • Regulatory Affairs Managers and RA SME's
  • Quality Managers
  • Design, Development, Manufacturing and Marketing Managers
  • Auditors
  • 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
  • Project Leaders for MEDDEV and CER Compliance

Day 1 Schedule

Lecture 1:
Clinical Evaluation Report and MEDDEV

  • Define Scope and Plan the Clinical Evaluation
  • Clarification: Frequency of updates to the Clinical Evaluation Report (CER)
  • Identification of Pertinent Data
  • Appraisal of Pertinent Data
  • Analysis of Clinical Data, Draw Conclusions
  • Finalize the CER: What should it look like?
  • New requirement: Qualifications of report authors and evaluators
  • Specific and measurable objectives for the CER
  • Establishing the state of the art
  • Scientific validity of data
  • Equivalence
  • Access to data for equivalent devices
  • When is a clinical investigation required?
  • Risk-benefit
  • Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)
  • Table of Contents for a CER (example)
  • Given the guarantee that all clinical support documentation is going to need to be re-evaluated and revised to meet the new legislative criteria under the new MDR, coupled with the realization that Notified Bodies are going to be inundated, we need to embark on clinical compliance now

Day 2 Schedule

Lecture 2:
Clinical Evaluation Report and MEDDEV

  • CER Assessment
  • Clinical Evaluation Plan and Strategy
  • Clinical Literature Review Safety and Performance and Examples
  • Preparing, writing and filing a new CER
  • Conducting a comprehensive literature review and formal assessment
  • Conduct a Literature Review in a few easy steps
  • Performing yearly gap analyses of MEDDEV regulations versus the existing CER
  • Creating timelines for updating existing CERs, training staff
  • Updating existing CERs
  • Ensuring compliance with new requirements
  • Any upfront or follow-on processes that may help drive commercialization
  • Clinical Evidence"? Put simply:
  • Clinical Data + Expert Review = Clinical Evidence
  • References and Guidance
  • Industry Trends

Lecture 3:
Consulting Case Study Practice

  • Participants role play consulting with instructor on CER examples
  • Avoid frequent pitfalls of clinical regulatory submissions
  • Provide robust documentation in support of the clinical safety and performance of your device
  • Ensure continuing compliance throughout device lifecycle

Lecture 4:
Case Study Practice

  • Practice on a project relevant to participants' organization
Best Practices and Trends - A good clinical evaluation is not just a European thing. It can be enormously helpful in a 510(k) in addressing equivalence with predicate device(s). After all - that's what a literature review is partly doing - looking at (all the) other devices in the market and their performance as it is relevant to your device.

Lecture 5:
Interactive Exercises and Discussions

  • Case studies
  • Examples
  • FAQ's
  • Q&A

Questions and Summary
Recap of Day 2

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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.

Location: Zurich, Switzerland Hotel: Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

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