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

Dan O'Leary, President at Ombu Enterprises, LLC
Coming soon.. Please contact customer care for new schedule

Course "Understanding and Implementing the Medical Device Directive" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

  • Do you have a clear understanding of how to put the CE Mark on a medical device?
  • Does the complexity of the product directives confuse you?
  • How up-to-date is your organization on the new standards for EU medical device quality systems and risk management EN ISO 13485:2012 & EN ISO 14971:2012?

Attend this two-day interactive course and get a better understanding of the Medical Device Directive (MDD) and its latest implementation tools.

This course will address the details of the MDD and includes other significant issues such as the Quality Management System (EN ISO 13485:2012), Risk Management (EN ISO 14971:2012), Clinical Evaluation (MDD Annex X), the role of harmonized standards, and the vigilance system.

This seminar will provide attendees a comprehensive training on how to classify devices, select the appropriate conformity assessment path, prepare the required documentation, and maintain it.

This course will also include practical exercises that apply the principles and help solidify learning. Attendees will receive detailed checklists that help classify devices, analyze and apply the essential requirements, and conduct internal quality audits.

Training Insights

As a bonus, attendees will get the following benefits:

  • An analysis of the risk management issues raised by EN ISO 14971:2012
  • A roadmap to convert your current risk management system to the EU requirements
  • A breakdown of EN ISO 13485:2012 and its relationship to the MDD
  • An explanation of the EU’s proposed regulations for medical devices

Learning Objectives:

  • Understand the role of product directives in the EU
  • Learn the medical device classification system and how to apply it
  • Comprehend the conformity assessment paths and how they apply to particular devices
  • Learn the role of EN ISO 13485:2012 and its relationship to conformity assessment
  • Understand the requirements for Risk Management and the use of EN ISO 14971:2012
  • Understand the MDD Essential Requirements and document compliance
  • Learn the role of the harmonized standards in demonstrating the Essential Requirements
  • Integrate the Clinical Evaluation in the MDD into the essential requirements and risk management processes
  • Apply the vigilance system including reporting, Field Safety Corrective Action, and Field Safety Notice
  • Prepare for Unannounced Inspections

Who will Benefit:

This course will benefit personnel involved in quality or regulatory compliance for medical devices marketed in the European Union and it is ideal for quality, regulatory, and clinical professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.

  • Regulatory Managers
  • Quality Managers and Directors
  • Marketing Managers
  • Clinical Managers
  • Export Compliance Managers

Topic Background:

The MDD can be complicated, especially for US companies, because the MDD’s approach is not the same as the regulatory approach in the US. For example, under the MDD your company makes “submissions” to a private company that you hire, not to a government agency. In addition, things are changing in the European Union. The new standards for quality systems and risk management (EN ISO 13485:2012 & EN ISO 14971:2012) are confusing to implement. Moreover, the EU has proposed a set of regulations that will replace the current directive system.

Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4:00 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)

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

Unannounced Inspections

  • Unannounced Inspections

Proposed EU Medical Device Regulations

Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

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

He 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. He 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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Palo Alto, CA 94303

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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Location :

Special Offer for the attendees of this seminar:

Rooms available at only $215 per night.

Please note: Hotel rooms are limited and based on availability

View Larger Map

How to Reach

General Driving Directions:

Driving Directions from Chicago O'Hare International Airport – ORD: 16 mile(s) NW
  • Take I-190 East to I-90 (Kennedy Expressway) East to the Ohio Street Exit. Ohio Street is a one-way street eastbound.
  • Take Ohio to State.
  • Turn right on State, and go to Hubbard (3rd light).
  • Turn left and hotel entrance is on the left.

From Chicago Midway International Airport - MDW : 10 mile(s) SW
  • Take Cicero Avenue north to I-55 North
  • Take I-90/94 west into downtown
  • Exit Ohio St (one-way eastbound)
  • Make a right on State and hotel is on the corner of State & Hubbard.

Other Transportation:

Bus Station
  • Greyhound Bus Lines: 1.8 mile(s) SW

Subway Station
  • Red Line (Grand Ave): 0.2 mile(s) N

Train Station
  • Union Station (Amtrak & Metra): 1.7 mile(s) SW

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

Media Partners


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  • Article on the Magazine and/or Website after the conference.

Local Attractions

One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.

The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.

Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!

With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.

You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.

A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.

Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.

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