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
Note: The EU intends to replace the current directives on medical devices with a set of regulations. The negotiations are ongoing and behind schedule. This seminar covers the directives, but provides also provides information on the proposed regulations.
Medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different from 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, requirements are constantly changing in the European Union. For example, the harmonized standards for quality systems and risk management (EN ISO 13485:2012 & EN ISO 14971:2012) are confusing for device manufacturers to implement. The need to keep product documentation current with updates to the harmonized standards provides an additional resource need on device manufacturers.
This interactive two-day course helps you understand the details of the MDD and implement the requirements. Attendees will learn how to classify devices, select the appropriate conformity assessment path, prepare the required documentation, and maintain it. During the course, participants have an opportunity to apply these concepts and principles with a large number of exercises.
The seminar addresses 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), and the role of harmonized standards.
Attendees receive detailed checklists that help classify devices, analyze and apply the Essential Requirements, and conduct internal quality audits.
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
- Understand the role of product directives in the EU
- Learn the MDD medical device classification system and how to apply it
- Comprehend the conformity assessment paths and how they apply to particular devices
- Understand the MDD Essential Requirements and how to document compliance
- Learn the role of EN ISO 13485:2012 as the fundamental Quality Management System
- Understand the requirements for Risk Management and the use of EN ISO 14971: 2012
- Integrate the Clinical Requirements in the MDD into the essential requirements and risk management processes
Who will Benefit:
This course benefits anyone involved in quality or regulatory compliance for medical devices marketed in the European Union and 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
|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 “permission”
- Quality Management Systems
- Role of the FDA
- 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
- Using harmonized standards to satisfy the Essential Requirements
- Conformity assessment paths in the directives
- 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 (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 Medical Device Regulations in the EU
Meet Your Instructor
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.
Register by P.O. / Check
Yes, I want to attend "Understanding and Implementing the Medical Device Directive: 2-Day In-person Seminar".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
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.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ email@example.com
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
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.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
If you wish to partner with us for this event
contact us: firstname.lastname@example.org
call us: +1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner To Do
- Banner (min 728x90 or 468x60) on the media partner website.
- Insertion of the event in the event calendar, both printed and/or online.
- Announcement article of the conference on the magazine and/or website.
- Dedicated email blast to media partner’s subscribers.
- Article on the magazine and/or website after the conference.
If you wish to sponsor this event
contact Cruise Webster: email@example.com
call us: (207) 576-4173
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.