ComplianceOnline

For a new or modified medical device, product approvals are required prior to distribution. This course is intended to provide participants with a detailed list of documents and testing required for a 510(k) Notification submission to the US FDA and a Technical File for submission to a Notified Body for the CE Mark.

The first day of this 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products. The contents and rational for submitting a traditional, abbreviated and special 510(k) for a Class II Medical Device will be detailed. Labeling, Substantial Equivalence and Performance Testing for various medical devices will be detailed. In addition, the Refuse To Accept Checklist will be reviewed to help participants audit their 510(k) submissions for compliance to the checklist.

On day 2 of this course we switch gears to the EU and the requirements for the preparation of a Technical File. As an introduction, CE versus CE with a number, ISO 13485 or ISO 9001 Compliance versus Certification for a Class I device and what Annex to follow for the CE Mark will be explained. The contents of the Technical File will be detailed with examples of Essential Requirements Checklist, Clinical Evaluation Reports and Declaration s for Conformity will be presented. In addition, the key changes in the new Medical Device Directive will be reviewed.

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

Learning Objectives:

Upon completing this course participants will understand:

  • 510(k) Notifications:
    • Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
    • When to file for a new device, a change in the intended use or a change in the technology of a cleared device
    • What is contained in a traditional, abbreviated and special 510(k) submission package
    • What is substantial equivalence and what’s required to show substantial equivalence
    • What’s required on the labeling and IFU
    • Which performance tests should be conducted and how to present the data to the FDA
    • Understand the FDA’s Refuse to Accept Policy
    • What is required in a submission for software controlled devices
  • Technical File:
    • Formatting a Technical File
    • Determine Device Classification and Conformity Assessment Procedure
    • Essential Requirements Checklist Requirements
    • Clinical Evaluation Report Requirements
    • Risk Management Plan and Reports Requirements
    • Contents of a Declaration of Conformity
    • Key changes in the new Medical Device Directive

Who will Benefit:

This course is designed for individuals who are tasked with preparing a 510(k) Notification or Technical File for a Medical Device. The following personnel will benefit from the course:

  • Company CEOs and Presidents
  • Regulatory Affairs Managers
  • Quality Assurance Managers
  • Regulatory and Quality Assurance Professionals
  • Design Engineers
  • Quality Engineers
  • Legal Professionals
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • The 510(k) regulation
  • Types of 510(k) submissions
  • Preparation of a Traditional 510(k)
    • Substantial equivalence
    • Labeling requirements
    • Performance testing
    • Substantial equivalence
    • Risk management documentation
    • When are clinical trials required
  • When and what’s required for a Special 510(k)
  • When and what’s required for an Abbreviated 510(k)
  • Guidance documents and FDA recognized standards
  • FDA’s refuse to accept policy
Day 02(8:30 AM - 4:30 PM)
  • Review of the Medical Device Directive (MDD)
  • Technical File contents per the MDD
  • Determining product classification and rationale
  • Conformity Assessment Procedure
  • Essential Requirements Checklist Review
  • Risk Management Plan and Report Requirements
  • Product Information Requirements
  • Clinical Data Review Options
  • Labeling
  • Examples of various Declaration of Conformities
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James Barley

James Barley
Regulatory Affairs and Quality Assurance Consultant

James Barley is a founder of Abrimed Consulting Services, a Medical Device Regulatory Affairs and Quality Assurance Consulting company. Mr. Barley graduated from Lowell Technological Institute with a degree in Engineering and later earned his Masters of Business Administration from Pepperdine University. During the last 20 plus years, Mr. Barley has been consulting for small and medium sized medical device companies. These services included setting up quality systems compliant with the FDA’s Quality System Regulation, ISO 9001 and ISO 13485.

In addition, Mr. Barley has prepared 510(k) submissions for instruments, disposables, electronic equipment and software as well as Technical Files for Class Im, 1s, IIa and IIb. Since the FDA has begun enforcing its Refuse To Accept Policy, Mr. Barley has successfully navigated through the requirements of the FDA Policy.

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$1,199.00

Seminar One Registration

August 3-4, 2017, San Diego, CA
(Registrations till June 10, 2017 - $1199)
(Registrations till July 10, 2017 - $1299)
(Registrations after July 10, 2017 - $1499)

$1,699.00

Seminar One Registration (With 2 Nights Stay)

August 3-4, 2017, San Diego, CA

$5,599.00
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August 3-4, 2017, San Diego, CA
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Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


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

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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.

Location

San Diego, CA
(Venue to be announced shortly)

August 3-4, 2017

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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
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  • Exclusive stall at the entrance
  • A full page brochure advert
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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San Diego Cabrillo National Monument

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Legoland

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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 Island

Coronado Island

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.

Balboa Park

Balboa Park

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.

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