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Course Details
Price:
$1,395 15 seats left
Start Date:

Mon, Mar 02, 8:30am - Mar 04, 5:30pm (3 sessions)

Location:
Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752
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Description
Class Level: All levels
Age Requirements: 18 and older
Average Class Size: 15

What you'll learn in this business training:

This course has been designed to understand European directives, CE marking and guidance documentation.

Course Benefits
Participants will understand EU directives and related directives (objectives, history, structure, purpose).

Who Should Attend?
The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations), medical device manufacturers who desire to export to Europe.

Topics Covered

  • Conformity assessment paths
  • Requirements for safety / health / environment / consumer protection
  • Medical device classification systems / Medical device classification in the EU (by directive)
  • Risk Management and its relation to medical device directives
  • The application and differences of the directives that cover medical devices
  • European approval process and how to plan
  • The conformity assessment paths in the directives
  • EN medical device safety assessment procedure.
  • Annex II – Full Quality Assurance System
  • Relationship to other product directives
  • EN ISO 9004-1 using medical device guidance documents (EN 50103, EN 928), and combining it with ISO 9001, ISO 13485
  • Compare & Contrast EU & FDA Procedures and Requirements
  • Development, aims, and implementation of medical device directives in the EU
  • EU Directives overview & their impact: (developing/marketing new medical device products) * Active Implantable Medical Device Directive (AIMDD) * Medical Device Directive (MDD) * In Vitro Diagnostic Device Directive (IVDD).
  • EU medical device directives - key relationships / vigilance program
  • Compliance Options by Device Class
  • Key definitions / terms, conformity assessment procedures, QSR
  • Guidance documentation (directives implementation
  • Technical files and Design Dossiers
  • Using harmonized standards to satisfy the Essential Requirements

Prerequisites:

Medical Device background, those in quality / regulatory affairs responsible for preparing / working with CE Marking Audits, those in U.S. and Canadian organizations that are new to the European Union market; those performing risk analysis / design for medical devices (development); and those companies in preparation of their own private label of medical device (marketed in Europe).

Please Note: Price includes materials, and certificate of attendance

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Refund Policy
REFUND POLICY: (AS PER M.G.L. CHAPTER 255, SECTION 13K)
  1. You may terminate this agreement at any time.
  2. If you terminate this agreement within five days you will receive a refund of all monies paid, provided that you have not commenced the program.
  3. If you subsequently terminate this agreement prior to the commencement of the program, you will receive a refund of all monies paid, less the actual reasonable administrative costs described in paragraph 7.
  4. If you terminate this agreement during the first quarter of the program, you will receive a refund of at least seventy-five percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  5. If you terminate this agreement during the second quarter of the program, you will receive a refund of at least fifty percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  6. If you terminate this agreement during the third quarter of the program, you will receive a refund of at least twenty-five percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  7. If you terminate this agreement after the initial five-day period, you will be responsible for actual reasonable administrative costs incurred by the school to enroll you and to process your application, which administrative costs shall not exceed fifty dollars or five percent of the contract price, whichever is less. A list of such administrative costs is attached hereto and made a part of this agreement.
  8. If you wish to terminate this agreement, you must inform the school in writing of your termination, which will become effective on the day, such writing is mailed.
  9. The school is not obligated to provide any refund if you terminate this agreement during the fourth quarter of the program.

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Quality & Productivity Solutions, Inc

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Start Dates (1)
Start Date Time Teacher # Sessions Price
8:30am - 5:30pm TBD 3 $1,395
This course consists of multiple sessions, view schedule for sessions.
Tue, Mar 03 8:30am - 5:30pm TBD
Wed, Mar 04 8:30am - 5:30pm TBD

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