Document List and Pricing

Document Name  Pricing
Software Life Cycle  $489
Code Review Form  $299
ISO 14971 Checklist  $249
Level of Concern Form  $229
Software Hazard Analysis Procedure  $299
Software Hazard Analysis Form  $249
Non-Product Software Determination & Risk Assessment Form  $229
Product/System/Software Requirements Procedure  $299
Software Requirements Specification Template  $249
Risk Management Procedure  $299
Software Coding Standards  $299
Configuration Management Procedure  $299
Software Configuration Management Plan Template  $299
Software Design Description Template  $299
Medical Software Design and Development Procedure  $299
Medical Software Design and Development Plan Template  $249
Software Design-Architecture Description Template  $299
Software Verification and Validation Procedure  $299
Software Design Verification Plan Template  $299
Unit Test Procedure  $299
Unit Test Plan Template  $249
Unit Test Protocol Template  $249
Unit Test Report Template  $249
Unit Test Report Traceability Matrix Template  $229
Software Integration Test Procedure   $299
Software Integration Test Plan Template  $299
Software Integration Protocol Template  $249
Software Integration Test Results Template  $249
Software Integration Test Results Report  $249
Software Traceability Report Form  $229
Software Verification Protocol Template  $249
Software Verification Report Template  $249
Completing The SOUP Form Work Instruction  $249
SOUP Form  $229
System Verification Procedure  $299
System Verification Protocol Template   $249
System Verification Report Template   $249
System Traceability Report Form  $229
Unresolved Anomaly Report Template  $129
Peer Review Cover Sheet  $129
Attendance Sheet  $129
Non-Product Software Validation Process  $299
Downstream Validation Process  $299 

Complete Procedure and Template Set Without System Verification SOPs and Templates

$9932

 Complete Procedure and Template Set*

*A savings of over $500

$10620

Why Buy This System?

One major reason for purchasing Standard Operating Procedures (SOPs) and Templates to accompany them instead of writing them yourself, is to ensure you are providing exactly what regulatory bodies consider compliant...No Less, but more importantly...No More.

Many Quality Assurance consultants bring in their SDLC systems from the last company they worked for or from other industries. These systems can contain uneccessary requirements which can be unduly burdensome and costly.

The other major reason is that you will have a fully implemented robust Software Life Cycle rapidly with no guessing as to whether it is compliant or not. A Quality Process this complete can take 6 months to a year to create.

Yes, you may have to do some customizing to fit your needs, but you will not have to create them from scratch.

These procedures, created by Software Professionals and 62304 experts, will meet the requirements for early-stage medical device companies. What is more important, they will stand up to the closest scrutiny from Auditors since they demonstrate clearly complete compliance.

But just having the Procedures is not enough. You need to ensure that your personnel are also following those procedures and find it easy to do so. Templates are the way to ensure "compliance in action."

Key Features

  • Written specifically for early stage medical device companies although will standup in larger company environments wanting to start to write software.
  • Create a ready made off-the-shelf Software Quality System for your company
  • Includes free updates for 62304/GPSV/14971/Title 21 CFR11 as they become available
  • Can be used for FDA 483 responses
  • Are audit ready
  • Incorporates risk management into each procedure

CONTACT INFO:

Email:
info@signetmedicalsystems.com

1-978-270-5053



Access the FREE  Report:

List of Essential Documents and Templates You Need for IEC EN62304 Compliancy

Enter Your Information in the Form Below and Press the Submit Button.

Join our mailing list

Complete the form below to subscribe to our email newsletter.

     *
     *
     *
     *
     *

    *Required field

     

     

    SPAM Policy: We will not give out or rent your email address to anyone.