Writing Templates

Quality System Implementation Templates  

Ready-to-use QSI Templates

If your company requires specific solutions for MedTech compliance, our QMS templates are precisely tailored to meet your needs. Explore excellence with CQG’s ready-to-use quality system implementation templates. These documents ensure compliance, empowering your organization with simplicity and efficiency. Elevate your quality journey with templates that are meticulously designed to align with your unique requirements and goals.

Available Templates

**Note – Templates are for an already developed paper system and do not include SOPs or Work Instructions on requirements and how to implement them.

Design & Development
Template Pack

  • Design & Development Plan
  • Design Review
  • Design Verification / Validation Plan
  • Test Method Validation Protocol
  • Design Traceability Matrix
  • User Requirements Document
  • Design Input Requirements
  • Design Specifications
  • Bill of Material / Device Master Record

Software Development Lifecycle
Template Pack

  • Software Development Plan
  • Product Requirements Specification
  • Architecture document
  • Software Requirements Specification
  • Cybersecurity plan
  • Computer System Validation

Production Controls
Template Pack

  • Corrective or Preventive Action Forms
  • Complaint investigation reports
  • Quality Dashboard
  • Equipment Qualifications (IQ/OQ)
  • Supplier Qualifications forms
  • Supplier Agreements
  • Management Review Template
  • Nonconforming Material Report
  • Rework Instructions
  • Quality System Deviations

Clinical
Template Pack

  • Clinical Monitoring Plan
  • Clinical Evaluation Plan / Report
  • Post Market Surveillance Plan / Report
  • Post Market Clinical Followup Plan
  • Post Market Clinical Follow up Evaluation Report

Do you have a good way of staying on top of your quality system commitments? Get our free Management Review Checklist.

Does your company need assistance with medical writing? Our certified medical writers possess detailed knowledge of the complex MedTech landscape.

Download the Alio Case Study now to discover how CQG helped Alio stay organized and on track through every step of their journey.

Cannon Quality Group (CQG) was founded in 2010 as a full-service outsourced quality management company serving the medical device, Medtech, pharma, IVDR, SaMD, and general life science community with right-sized quality management system solutions.

Contact

(925) 232-1003‬

Cannon Quality Group, LLC
77 Front Street
Danville, CA 94526