Course Description:
Most 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 than 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.
This interactive two-day course will help you comprehensively understand details of the MDD and implement its 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 will have exercises that apply the principles and help solidify learning.
The instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards.
Course 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
- Understand the Essential Requirements and how to document compliance
- Learn the role of ISO 13485 as the fundamental Quality Management System
- Understand the requirements for Risk Management and the use of ISO 14971
- 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
Course Outline:
Day 1 |
Day 2 |
Medical Device Directives
Compare & Contrast EU & FDA Procedures and Requirements
Understanding the MDD
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Quality Management Systems
Risk Management Systems
Clinical Evaluation
Post Market Surveillance
Safety and Surveillance
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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. |
Register Now
Online using Credit card
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Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
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USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.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 protected]
Payment:
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.
Testimonial
With the simple approach take by Dan, anyone can learn how to complete a successful MDD implementation.
- Quality Specialist, Rochester Medica
Dan OLeary displayed complete and total Mastery of the subject in this presentation, and in his answers to the questions asked from him.
- Quality Manager, Parker Hannifin Corp
I enjoyed Dan's course very much. The Instructor and materials were excellent and the information he taught will be very helpful to my Company.
- Compliance Coordinator, Diagnostica Stago, Inc.
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