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Centralize Design Control Data 

  • Eliminate data silos: Work in one system for accurate traceability and compliance. 
  • Template your process: Create templates for any design control process – including Design History Files (DHF), and even ISO 9001 design controls.
  • Create custom phases: Organize phases of design and development however works best for you. 

  • See design plans your way: Customize design plans with the most relevant information for your team. 

  • Manage Technical Files: Centralize Device History Records (DHR), Design History Files (DHF) and Device Master Records (DMR).
  • Connect your data: Link multiple QT9 QMS modules such as document control, ECR, ECN, FMEA, risk assessments, and inspection plans per phase.
Design Control Software
Product Design Timeline

Get Total Traceability

  • Manage communications: Choose which team members are responsible parties, pre-assign approvers and approval levels. 
  • Create custom fields: Capture the right data to drive consistency. Choose between different field types, like multiple options, text, or numbers.
  • Manage anything: Build out a complete design and development package per product, product category, or even groups of products.
  • Get status updates: Get automatic updates to design data, so everyone is on the same page.
  • Build out complete design & development packages:

    Link with multiple modules to build out  complete design and development packages per product, product category or groups of products.  

Automate Compliance Steps

  • Create Steps/Phases: Build custom steps/phases to match product design compliance with any standard.
  • FDA 21 CFR Part 820 and ISO 13485:2016 Compliance: Easily document and unify data for medical device FDA and ISO audits. 
  • cGMP Compliance: Current Good Manufacturing Practices (cGMPs) require proof of proper handling for every step of medical device production. QT9 makes it easy. 
  • FDA 21 CFR Part 11 Compliance: Review and electronically approve documents with FDA 21 CFR Part 11-compliant electronic signature approvals.
  • Maintain Design History File (DHF): Quickly prove that you have satisfied design controls for a review, inspection or audit.
Product Design Phases

Streamline Document Control 

  • Attach unlimited files: Access files from anywhere, and add resources so everyone is on the same page. 
  • Collaborate with teams: Share read-only links with customers, suppliers and employees that enable them to view items securely. 
  • Revision level controls: Assign users to approve, reject or verify documents.
  • Automate training: Trigger training events by linking documents to training. 
  • DHF Accessibility: QT9 makes it easy for your entire team to access Design History Files and keep them up to date. 
Document Control Software

Free Up Time with Product Design Tools Built In To QT9™ QMS.

QT9's product design platform is your all-in-one solution for better product design.

Automate Design Controls

Templates are available for any design control process, including DHF & ISO 9001 requirements.

Create Custom Phases

Create custom phases of design and development.  

Responsible Parties

Pre-assign approvers and create responsible parties.

Improve Traceability

See a timeline of every action along with lot and serial traceability.

Get Real-Time Analytics

Make informed decisions with real-time dashboards. Create your own custom views.

Ensure Compliance

Show proof of proper handling, supporting FDA Current Good Manufacturing Practices (cGMPs).

Error-Proof Production

Identify and mitigate risks associated with batch production and compliance. 

Link Records

Easily link design history files to documents, audits, inspections and more. 

See What Quality Leaders Say About QT9

Capterra-5-Star-Review

"All of our records are now in one location"

QT9 has streamlined our internal auditing process, preparation for regulatory audits, document control and approval, and organizational training. We have been able to reduce our active documents by 30% as unnecessary/redundant documents and procedures have been made more visible through the document review process.


Reviewed on Capterra
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Jennifer B.
Medical Device Industry
Small-Business (11-50 emp.)

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Capterra-5-Star-Review

"Looking forward to using more modules"

The document control feature has improved our ability to find documents and some records when requested for audit or project purposes. Training is much easier to manage. I like being able to link equipment and gages to system documentation in the Document list. The customer service has always been helpful and responds quickly.


Reviewed on Capterra
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Bill C.
Medical Device Industry
Mid-Market (51-200 emp.)

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Capterra-5-Star-Review

"Excellent support, traceability and ease of use."

We are a medical device company and myself, the FDA & ISO auditors liked the traceability, control of documents and everything was there at our fingertips from Management review to Documents to CAR's. QT9 is always responsive to our questions and resolving issues. For the cost, the flexibility, electronic signature and traceability is worth trying out the system.


Reviewed on Software Advice
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Reba D.
Medical Device Industry
Director of QA/RA

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Connect All the Tools You Use for Product Design and Development

QT9 QMS enables you to integrate multiple quality process with product design.

Document Control

Audit Management

Risk Management

CAPA Management

Management Review

NCPs

Supplier Evaluations

Supplier Surveys

Supplier Web Portal

Customer Feedback

Customer Surveys

Customer Web Portal

Calibrations

Preventive Main.

Change Control

Project Management

Safety Management

Employee Training

Deviation Mgmt.

ECNs

FMEA

Inspections

Design Controls

Quality Events

Proven Impact Across Organizations

Explore how your team can use QT9 QMS to work efficiently and drive results.

Blog Post

FDA 21 CFR Part 820 and ISO 13485 Harmonization for Medical Devices

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Blog Post

ISO 13485 Software Guidelines

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Blog Post

Importance of Automating Document Control for Medical Device Companies

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All-In-One Medical Device Software

QT9 QMS makes it easy to improve your design processes and grow into fully-integrated solutions. Documentation, inspection plans and file attachments can be synced to your Bill of Materials (BOM) with QT9 ERP to create a complete eDHR or eDMR in once click. No paper needed. No separate folder structures. 

Frequently Asked Questions: Design Controls

What are design controls?

Design controls are a set of quality practices and procedures that play a continual role in both premarket and postmarket medical device development.

Design controls manage the design process to assure that medical devices meet user needs, intended uses and specified requirements to improve and prevent future issues. 

Who do design controls apply to?

Design controls apply to all Class II and Class III medical devices. 

Design controls apply to the following class I medical devices:

1. Devices automated with computer software
2. Tracheobronchial suction catheters
3. Surgeon's gloves
4. Protective restraints
5. Manual radionuclide applicator system
6. Radionuclide teletherapy source

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