Understanding and Implementing the Medical Device Directive: 2-Day In-person Seminar

By: Dan O'Leary, President at Ombu Enterprises, LLC
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Course Description:

The US medical device regulations include Part 820, the Quality System Regulation, but extend far beyond them. In order to understand the regulations, you need to look at more than just the quality management system. This course provides an overview and explains how the parts of the regulations fit together. The seminar helps you understand the four major parts of the US regulatory structure: laws regulations, guidance, and consensus standards.

Risk class and the panels, established by law, characterize medical devices in the US. Device types fall under regulations and product codes that determine the pre-market submission pathways and provide requirements for specific cases.

The Quality System Regulation, in Part 820, provides the quality management system required to market medical devices in the US. Device design, production, installation, and servicing fall under Part 820. This part of the regulations include management responsibility for the system, design requirements, purchasing, manufacturing processes and controls, release for distribution, record keeping, etc.

After release, a device is subject to a variety of other requirements ranging from UDI to complaint management to medical device reports. Each of these requirements is in a separate part of the regulations.

This course provides a comprehensive view of the regulatory requirements to help you understand the whole picture and provide effective implementation for your company.

Why Should You Attend:

People who work in medical devices are not always able to see the complete structure of the regulations and how they fit together. In the US regulatory structure the parts are linked and intertwined. For example UDI implementation is in about six parts of the regulations. Medical Device Reports, in Part 803, must link with complaints in Part 820.

This course provides explains how all of this fits together. Whether you are an experienced professional or a person just entering the field, this seminar provides the information you need to understand and stay current with the US regulatory structure.

Areas Covered:

  • Distinguish among the law, regulations, and policies that FDA applies for medical device
  • The concepts of pre-market approval including device classification and pre-market submissions
  • The quality management systems that govern the design, manufacture, installation, and servicing of medical devices distributed in the US
  • The role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
  • FDA’s inspection documentation tools including the FDA forms 482, 483, and 484.
  • Utilization of Warning Letters to understand the regulatory issues

Who will Benefit:

While the course is specific for medical device manufacturers, any company in the medical device supply chain can benefit. It is ideal for:

  • Quality Managers
  • Quality Engineers
  • Regulatory Affairs Managers
  • Regulatory Affairs Professionals
  • R&D Managers
  • R&D Engineers
  • Product Design and Development
  • Operations Managers
  • Production Managers and Supervisors
  • Manufacturing Engineers
  • Risk Managers
  • Complaint system team members
  • CA&PA team members
  • Medical/Marketing Personnel

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Medical Device Directives

  • Development, aims, and implementation of medical device directives in the EU
  • The application and differences of the directives that cover medical devices
    • The Medical Device Directive (MDD)
    • The Active Implanted Medical Device Directive (AIMDD)
    • The In Vitro Diagnostic Medical Device Directive (IVDD)
  • Relationship to other product directives
    • Machinery Directive
    • Personal Protective Equipment Directive

Compare & Contrast EU & FDA Procedures and Requirements

  • Device classes
  • Marketing “approval”
  • Quality Management Systems
  • Role of the Notified Body

Understanding the MDD

  • Medical device classification in the EU (by directive)
  • Software as a medical device
  • Technical File and Design Dossier
    • Constructing and maintaining the documentation
    • Auditing and sampling by the Notified Body
  • Annex I – Essential Requirements
  • Harmonized standards and the Essential Requirements
  • Conformity assessment paths in the MDD
    • Compliance Options by Device Class
    • Annex II – Full Quality Assurance System
  • Information Provided by the Manufacturer (Labeling & IFU)
Day Two (8:30 AM – 04:00 PM)

Quality Management Systems

  • EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes

Risk Management Systems

  • EN ISO 14971:2012 Medical devices – Application of risk management to medical devices

Clinical Evaluation

  • Clinical Evaluation (MDD Annex X & MEDDEV 2.7-1)

Post Market Surveillance

  • Medical Device Vigilance System (MEDDEV 2.12-1)

Safety and Surveillance

  • Creating a unified approach during the development and production phases
  • Creating a unified approach for activities after delivery

Proposed EU Medical Device Regulations

Meet Your Instructor

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Dan O'Leary
President at Ombu Enterprises, LLC

Dan O'Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

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