ComplianceOnline

Register

Toll Free: +1-888-717-2436




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

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

Course Description:

The Medical Device Directive (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.

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 will help participants understand the details of the MDD and implement the requirements. They 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 an opportunity to apply these concepts and principles with a large number of exercises.

The seminar will address the details of the MDD and include 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 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 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 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:

Medical devices marketed in the European Union must follow the MDD; IVD device and active implantable devices have other directives.





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
  • 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 and 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

Proposed EU Medical Device Regulations






Meet Your Instructor

Dan O'Leary
President at Ombu Enterprises, LLC

Daniel 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 master’s degree in mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Mr. O'Leary is a regular speaker at international conferences including ASQ, ISM, and RAMS. He teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Mr. O'Leary 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 Online


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com


Register by P.O. / Check


Yes, I want to attend "Understanding and Implementing the Medical Device Directive: 2-Day In-person Seminar".

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
USA

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

Register by Wire Transfer




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 @ editor@complianceonline.com

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.

Media Partners

Sponsors



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.






Local Attractions

The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.




Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.




Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.




The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.




Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.




Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.




In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.






Follow us :
We need below information to serve you better