Top menu

risk_management_plan

Risk management plan template (medical device and ISO 14971)

$49.00

How can I get this and other templates for free? Become a subscriber.

This template will provide you with a framework to complete your risk management plan. It may also be used as a benchmark on your existing plan. The template includes topics as required by clause 3.4 of ISO 14971:2007, 2009 and 2012. It also includes topics that should be addressed for software risk management according to IEC 62304:2006.

SKU: rm_template_premium_feb2017 Category: Tags: , ,

Product Description

Why it is useful
A risk management plan is required because an organized approach is essential for good risk management, the plan provides the roadmap for risk management, encourages objectivity and helps prevent essential elements being forgotten.

How to use it
1. If you are developing a brand-new product, establish as much as possible of this plan in the planning phase of your project.
2. If you are making a revision of an old product, or adding a product to a range that this plan applies to, the plan might only have to be updated slightly.
3. Note that the plan shall be maintained, that is, it should reflect what you are doing and the other way around.

Add to cart and download.

You may also like…

  • risk_management

    Risk management for medical devices and ISO 14971 online training

    Free 30 minute online taster course, course certificate

    We provide a free, web-based 30 minute taster course to give you an introduction to risk management. The full course  equips you with a course certificate and – naturally – a great deal more information on how to perform risk management according to ISO 14971.

    $299.00 MORE INFO