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Risk Management for Medical Devices

at Quality & Productivity Solutions, Inc -

Course Details
Price:
$1,295
Start Date:

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Important:
Price includes materials, certification.
Description
Class Level: Intermediate
Age Requirements: 18 and older
Average Class Size: 10

What you'll learn in this iso training:

Risk Management for Medical Devices (ISO14971:2007 & EN ISO 14971:2012)

This course has been designed to help you understand the requirements for understanding, analyzing, and managing medical device risk using ISO 14971:2007. Participants will understand the standard, determine documentation requirements, and develop implementation strategies. The course also describes the issues raised by the European Union version, EN ISO 14971:2012.

Course Benefits

Participants will understand the requirements of the risk management process including plan, analysis, evaluation and risk reduction.

Prerequisites:

Knowledge of medical device regulation

Topics Covered:

Scope
Terms and definitions
General requirements for risk management

  • Risk management process
  • Management responsibilities
  • Qualification of personnel
  • Risk management plan
  • Risk management file

Risk analysis

  • Risk analysis process
  • Intended use and identification of characteristics related to the safety of the medical device
  • Identification of hazards
  • Estimation of the risk(s) for each hazardous situation

Risk evaluation
Risk control

  • Risk reduction
  • Risk control option analysis
  • Implementation of risk control measure(s)
  • Residual risk evaluation
  • Risk/benefit analysis
  • Risks arising from risk control measures
  • Completeness of risk control

Evaluation of overall residual risk acceptability
Risk management report
Production and post-production information

Who Should Attend?

Individuals interested in learning how to develop and deploy risk methodologies including implementing ISO 14971.


Remote Learning

This course is available for "remote" learning and will be available to anyone with access to an internet device with a microphone (this includes most models of computers, tablets). Classes will take place with a "Live" instructor at the date/times listed below.

Upon registration, the instructor will send along additional information about how to log-on and participate in the class.

Still have questions? Ask the community.

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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School: Quality & Productivity Solutions, Inc

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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