ComplianceOnline

At this workshop, John Riggi (40+ years of experience) will walk you through to get familiar with the medical device regulations in the following twelve (12) countries.

United States EU Canada Argentina Australia Brazil
India Japan Mexico Russia South Korea Taiwan

This workshop is intended to provide guidance on medical device classification and registration requirements in these countries.

During this workshop (1st day), medical device regulations of twelve countries will be discussed.

On the second day, we will discuss ISO 13485, ISO 14155, ISO 14971, GHTF documents, and MEDDEV guidance documents, etc. for quality and adverse event reporting including group discussions facilitating interpretation, understanding, and implementation of medical device regulations.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Why Should You Attend:

Understanding global medical device regulations and requirement and adequate implementation of applicable medical device regulations can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.

At this workshop, you will get familiar with medical device regulations of twelve (12) countries concerning medical devices, active implantable medical devices and in vitro diagnostic medical devices for adequate implementation and successful registration.

The following areas will be discussed during workshop:

  • Medical device regulations in US, EU, Canada, Argentina, Australia, Brazil, India, Japan, Mexico, Russia, South Korea, Taiwan
  • In EU, the following four Directives will be discussed.
    • DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
    • DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
    • DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
    • DIRECTIVE 2007/47/EC Amending MDD and AIMDD
  • ISO 13485
  • ISO 14155
  • ISO 14971
  • GHTF documents
  • MEDDEV guidance documents
    • Clinical investigation
    • Adverse event reporting

Who will Benefit:

This seminar will be valuable for anyone in the European Commission (EC) and FDA-regulated industry, including, but not limited to, medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This seminar will be particularly useful for those involved in research and product development, handling data and documents for regulatory submission for CE-marking purposes, conducting/monitoring/coordinating clinical investigation, and/or performing risk management and post-market vigilance/surveillance. This workshop is a must for those who are directly or indirectly involved in drafting and handling applications for CE marking purposes.

The following employees who will benefit include:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Research and development (associates, scientists, managers, directors and VPs)
  • Product and development (associates, scientists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Site managers, and consultants
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors
  • Anyone interested!
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM Registration Meet & Greet.
  • Medical Device Regulations in US and Canada
  • Medical Device Regulations in EU
  • DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD)
  • DIRECTIVE 90/385/EEC Concerning Active Implantable Medical Devices (AIMDD)
  • DIRECTIVE 98/79/EC Concerning in vitro diagnostic medical devices (IVDD)
  • DIRECTIVE 2007/47/EC Amending MDD and AIMDD
  • Medical Device Regulations in Argentina, Australia, Brazil, India, and Japan
  • Medical Device Regulations in Mexico, Russia, South Korea, and Taiwan
Day 02(8:30 AM - 4:30 PM)
  • ISO 13485
  • ISO 14971
  • ISO 14155
  • GHTF documents
  • MEDDEV guidance documents
  • Clinical investigation
  • Adverse event reporting
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
John Riggi

John Riggi
President and CEO, Lake Ontario MED DEV Consultants

With over 40 years of experience in the medical device industry, Mr. Riggi’s success spans the following industry sectors:

  • Ophthalmics
  • Orthopedics
  • High Volume Device Production
  • Cardiac Rhythm Management
  • Neurostimulation
  • Infusion Technologies
  • Medical and Dental Radiation Devices

Mr. Riggi brings this extensive experience to the client in the areas of:

  • Global Quality Assurance/Regulatory Operations
  • Global quality system development, implementation and assessment
  • Client assistance during third party/regulator audits, inspections and assessments
  • Medical Device Design Control
  • Radiation safety
  • Regulatory Compliance and Product Submissions
  • Client assistance in registration dossier preparation
  • Training on quality system regulations (US, EU, Canada, Brazil, China, Japan, Korea and Russia), MDSAP and EUMDR
  • Corporate Compliance Assessment Programs
  • ISO/CE Certification Processes
  • Vendor Quality
  • Enterprise Management System Leadership
  • Regulatory/Notified Body Relationships
  • Global medical device product registrations (US, EU, Canada, Brazil, China, Japan, Korea, Russia and numerous other jurisdictions in Latin America and Asia)

Whether on the manufacturing floor or in front of large conference audiences, Mr. Riggi’s open and relaxed communication talents ensure maximum value for the client.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,899.00

Seminar One Registration

May 28-29, 2020, Boston, MA
(For Registrations till April 25, 2020 - $1899)
(For Registrations after April 25, 2020 - $2299)

$8,995.00

Special Group Discount Register for Six attendees

May 28-29, 2020, Boston, MA
(For Registrations till April 25, 2020 - $8995)
(For Registrations after April 25, 2020 - $13795)




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

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 @ customercare@complianceonline.com

Payment:
Payment is required 2 days before 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 $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) 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 5 working days before 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 ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    Boston, MA
    (Venue to be announced shortly)

    May 28-29, 2020

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Testimonials

    See What People Say About Us

    I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.

    QC, Regulatory affair

    My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. The amount of interaction between the participants and presenters was ideal. I would also like to recommend this seminar to others.

    Regulatory Manager

    I think the instructor were very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.

    Regulatory Manager

    I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated by ComplianceOnline.

    Quality Analyst

    Speaker is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.

    QC, Regulatory Affairs

    All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. Overall it was good value for the price with ComplianceOnline.

    Managing Director

    ComplianceOnline Seminar offered a lot of valuable and relevant information. Thanks for organizing it very well and professionally. I would like to attend next seminar with in depth classification of medical device.

    Manufacturing Engineer

    Speaker was great. The event was well organized and coordinated by ComplianceOnline. I would recommend this to others. Thanks!

    Attorney (Patent)

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    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

    Media Partner:

    Media Partner

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    Local Attractions of Boston, MA

    Boston Public Garden

    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

    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

    Fenway Park

    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

    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

    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.

    North End

    North End

    This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

    Old North Church

    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.

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