Medical Device School's Products Page
Download procedures, forms, documents and e-books. Medical Device School is about saving you time and money. Keep checking this page for new additions.
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Hazard/Risk Analysis Worksheet Template
We will save you time, money and effort designing your Hazard/Risk Analysis Worksheet. Medical Device School's staff has put together a worksheet that combines ISO's 14971 requirements along with FDA's guidelines and requirements. Manage all your risks from one source. Also includes (for software) decision tree for determining "Level of Concern"; make final conclusions in one document.
Our template is intuitive and easy to use and combines procedure and form in one! All our templates are easy to modify so that you preserve the look and feel of your own quality system documentation.
File type: worksheet/procedure in one
Format: Microsoft Word
Price for download: $ 39.00 USD
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MDR Checklist
Dealing with a Medical Device Reporting (MDR) issue can be a stressful exercise. That's why we came up with a checklist to easily guide you (using a list of questions) through any potential reportable incident.
In addition, our form meets with FDA requirements by clearly demonstrating the decision pathway to reportability.
All our templates are easy to modify so that you preserve the look and feel of your own quality system documentation.
File type: Checklist
Format: Microsoft Word
Price for download: $ 17.99 USD
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Regulatory Evaluation of Changes
(For US FDA and Health Canada)
All changes to medical devices MUST be evaluated for their regulatory impact. Cleared (510k) and Approved (PMA) as well as devices that hold Canadian Medical Device Licenses - require special attention in reviewing, approving and recording the decision to submit for new application or not.
This extensive procedure provides you with all the tools - right down to the "considered memo" you will need to generate to maintain in your files as proof that your organization adequately reviewed all changes to your medical device.
All our procedures are easy to modify so that you preserve the look and feel of your own quality system documentation.
File type: Procedure
Format: Microsoft Word
Price for download: $ 59.00 USD
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Essential Principles Template
This is it! The essential principles template. It serves as the basis for allowing a manufacturer to demonstrate conformity with the Essential Principles of European Directives.
All our templates are easy to modify so that you preserve the look and feel of your own quality system documentation.
File type: Table/Worksheet
Format: Microsoft Word
Price for download: $ 39.00 USD
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When do Clinical Investigation Regulations Apply in USA?
This simple but powerful document outlines the various circumstantial inputs that go into deciding whether or not to invoke clinical investigation regulations when conducting tests in the USA.
Our staff carefully picked common variables (like whether or not a device has obtained it's clearance/approval) to serve as a basis for common decision making pathway.
All our templates are easy to modify so that you preserve the look and feel of your own quality system documentation.
File type: Guidance Document
Format: Microsoft Word
Price for download: $ 24.00 USD
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Engineering Change Notice (ECN) Form
Changes to medical device products require adequate documentation. That's why we came up with an Engineering Change Notice Form specifically designed for medical device products.
All our templates are easy to modify so that you preserve the look and feel of your own quality system documentation.
File type: Form
Format: Microsoft Word
Price for download: $ 14.95 USD
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Index of Canadian safety, Effectiveness, and Labeling Assessment
It's the best way to demonstrate compliance to Health Canada's Safety, effectiveness and labelling requirements!
The template is designed so you don't miss a requirement.
All our templates are easy to modify so that you preserve the look and feel of your own quality system documentation.
File type: Form/Table
Format: Microsoft Word
Price for download: $ 9.95 USD