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Medical Devices Regulations/QSR

Gain a comprehensive understanding of FDA requirements and learn how to implement Quality System regulations in the medical devices industry. This course is designed for engineers, quality professionals, auditors, and managers seeking to expand their knowledge of medical device regulations.

  • All levels
  • 18 and older
  • $1,095
  • 28 Lord Road, , Marlborough, MA
  • 18 hours over 2 sessions

Start Dates (0)

  • $1,095
  • QPS @ 28 Lord Road, Ste 205, Marlborough, MA 01752
  • 18 hours over 2 sessions
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Class Description

Description

What you'll learn in this medical training:

This course has been designed to help you understand the Quality System requirements including FDA perspective and how to implement.

Course Benefits

Participants will understand the QSR, FDA requirements and how ISO 9001 and QSR can be deployed.

Topics Covered:

  1. What are QS Regulations
  2. The FDA Philosophy
  3. Medical Device Overview
  4. Relationship to ISO standards
  5. The Quality System Regulations
  6. Quality Records
  7. Regulatory Requirements and FDA expectations
  8. Impact of QS Regulations on other industries
  9. The Quality System Inspection Technique
  10. Design Controls Understanding Medical Devices Regulations

Who Should Attend?

Individuals interested in learning the Medical Device Regulations which includes engineers, quality professionals, auditors, managers etc.

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.
In any event where a customer wants to cancel their enrollment and is eligible for a full refund, a 5% processing fee will be deducted from the refund amount.

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Quality & Productivity Solutions, Inc

Quality & Productivity Solutions, Inc. is an international firm dedicated to providing practical and effective consulting and training to achieve client objectives. Whether it’s improvement in process, product, service, or overall performance, exceptional results are our business. We partner with...

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Quality & Productivity Solutions, Inc

Quality & Productivity Solutions, Inc

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