2 Day Workshop: Preparing For The New EU Medical Device Regulations (MDR)

By: David R Dills, Regulatory Affairs & Compliance Consultant.
Product code: SEM31
Location 1: Burlingame, CA Feb 21 - 22

Description

Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS"

The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation.
The European Union released the Medical Devices Regulation (MDR 2017/745/EU) to eventually replace the Medical Devices Directive and Active Implantable Medical Devices Directive. The MDR introduces numerous changes, including a shift from the pre-approval stage to more of a life-cycle approach. It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges and transition smoothly to the MDR.
This seminar provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product lifecycle. You will gain a strong foundation of the key elements of the EU directives governing medical devices. These include: Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, Medical Devices Directive (MDD) 93/42/EEC and In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC in their latest revision, including the 2007/47/EC amendments to AIMDD and MDD. This course examines how devices are classified, and the effect classification has on labeling, registration, marketing and postmarketing requirements. Learn about the new requirements in the Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance; and more importantly learn how to plan an efficient transition.

Areas Covered

•     Understand the Medical Device Regulations approach in Europe
•     Understand the structure and purpose of the Medical Device Directives 
•     Explain the use of Essential requirements, including the use of (harmonized) Standards
•     Understand the key changes upcoming in the new EU MDR 
•     Understand the essence of early start in the transition 
•     Understand how to prepare a transition plan
•     Apply the Classification Criteria and Implementation rules
•     Identify the conformity assessment routes 
•     Identify Technical Documentation requirements 
•     Importance and Role of Clinical Data 
•     Identify the importance and contents of Post Market Surveillance
•     Explain and differentiate between the scope of the three EU device directives
•     Outline how medical devices are classified using the European regulatory framework
•     Identify the important contents of each EU directive
•     Discuss the general requirements of preclinical and clinical testing in Europe
•     Describe the conformity assessment pathways for obtaining CE marking
•     Cite the key requirements for postmarketing surveillance
•     Explain the overall regulatory requirements for medical devices in the EU
•     Comply with the implementation details and requirements of the EU MDR & IVDR
•     Develop a “systems approach” for data usability/management
•     Label and mark your products
•     Internalize the core data elements
•     Distinguish the similarities and differences
•     Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
•     Review and discuss pain points, challenges and solutions
•     Current and future trends 

Who will Benefit

This seminar is designed for new regulatory professionals and others in related departments interested in understanding the basics of EU regulation of medical devices and the impact on medical device companies. Participants and attendees will be provided with a stimulating and practical working environment. 

       • Senior Management 
       • Regulatory Affairs Managers and Quality Managers
       • Design, Development, Manufacturing and Marketing Managers
       • Auditors
       • Compliance/Regulatory affairs professionals
       • QA/QC professionals
       • Manufacturing managers, supervisors 
       • Project Managers
       • Compliance Officer
       • Compliance Specialist
       • Clinical Affairs
       • Marketing & Sales Management 
       • Distributors/Authorized Representatives
       • Legal Counsel
       • Consultants

Learning Objectives

•   Class I, II and III/In Vitro Diagnostic medical device manufacturers
•   Contract medical device manufacturers
•   Contract sterilizers
•   Repackagers, relabelers, specification developers, reprocessors of single-use devices
•   Manufacturers of accessories and components sold directly to the end user 
•   U.S. manufacturers of "export only" devices
•   Distributors 
•   Importers
•   User Facilities (e.g., hospitals, nursing homes)

Course Outline:

Day 1 Schedule

•          Introductions and Background
•          The objectives of the MDR
•          Scope & Definitions
•          Placing CE marked product on the market
•          EUDAMED and significance of the European Electronic Database
•          Notified Bodies
•          Classification and Conformity Assessment
•          Clinical Evaluation & Investigations
•          PMS and Vigilance
•          Quality management system requirements in the MDR
•          Device classification and conformity assessment routes changes in the MDR
•          Technical documentation requirements
•          Clinical evaluation process requirements 
•          UDI and traceability requirements 
•          Postmarket surveillance and reporting requirements 
•          Life-cycle review of products linked to risk management and clinical evidence
•          Implications for Notified Bodies, and for organizations working with Notified Bodies
•          Impact on product portfolios and classification
•          The need for improved clinical evidence
•          Strengthening of post market surveillance (PMS)

 

Day 2 Schedule

•         How can we prepare to recertify to the MDR?
•         Is there an efficient, cost-effective way to train our team on the MDR? 
•         General obligations of the medical device manufacturer
•         Uploading data and maintaining compliance with EUDAMED
•         UDI in Europe and how it compares with US FDA UDI requirements and traceability of the supply chain
•         Classifying medical devices under the European MDR
•         Conformity assessment procedures and the role of Notified Bodies
•         Safety and performance requirements
•         Navigating standards under 2017/745/EU
•         Clinical evaluations and “new rules” on adequacy of clinical data and clinical investigations
•         Clinical investigations and Clinical Research Organizations
•         Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
•         Vigilance requirements for Europe
•         Economic operator must verify that a previous economic operator has complied with the EU MDR requirements
•         EU MDR importation and distribution requirements expand regulatory due diligence from legal manufacturer to importers and distributors
•         The role of the Personal Responsible for Regulatory Compliance (PRRC)
•         Planning your transition to the MDR
•         Interactive Discussions
•         Review Regulatory and Compliance Documentation
•         Current Trends
Debrief/Adjourn/Wrap-Up

 

speaker

David R DillsRegulatory Affairs & Compliance Consultant

David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. 

He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. 

He 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; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. 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 and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working group

21-February-2018 To 22-February-2018 Burlingame, CA
Seminar One Registration
$ 1395



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Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

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It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

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This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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