Risk Analysis and Risk Assessment document template FMEA

$299.00

AN EASY WAY TO GET YOUR RISK ASSESSMENT APPROVED IN ONE SHOT!

  • Need to complete your risk assessment on time?
  • Want to be sure your risk assessment document will pass a regulatory inspection easily?
  • Do not have enough budget to hire a consulting company to complete your risk assessment?

FROM TODAY YOU CAN HAVE IT ALL:

Be in full compliance with the FDA/ICH regulations in a short time and with minor costs.

 

Description

This FMEA Risk Analysis and Risk Management template will enable you to identify, analyze, and evaluate risks and the impact of prioritization and assess the residual risks after mitigation activities implementation. This procedure template is based on the Failure Mode and Effect Analysis (FMEA) to evaluate the process and identify where and how it might fail, assess the relative impact of different failures, and ensure systematic identification, analysis, evaluation, and control of risks. The template includes a Risk Analysis table that enables monitoring the effectiveness of the control over risks and compliance with the FDA, Eu, and ISO regulatory requirements

 About this template

  • Versatile & easy to use risk assessment template
  • Immediate download
  • MS word, 26 pages ready to use risk assessment template
  • Based on the FMEA methodology
  • Clear instructions for use
  • Fits for FDA/Eu./ISO 13485/ISO 14971/HIPAA/GDPR regulations
  • Fit to Pharma/Medical/E-Health/Supplements and other industries

Your final Risk Assessment draft can be reviewed by our consultants- Optional

Benefits

Understand how our Risk Assessment template will support you best:

Best methodology and practice that fits your industry, products, and regulatory requirements

Have a template that is being used daily by our consultants in international FDA/CE/Eu audits

Improve your regulatory documents writing capabilities

Prepare your documents, based on smart & easy to use templates

Pass FDA/CE/Eu audits and submissions easily*

Immediate access to downloads

Be independent and keep professionalism in-house.

In Addition

Get access to hundreds of templates for your future needs

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Customized documents writing

Review your final document before final approval

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