Design & Development QMS Package
Build the Quality system behind your medical device development. As your device moves from early development towards a controlled product, your QMS needs to expand beyond the basic Quality foundation. Design activities, verification and validation, outsourced manufacturing, changes, nonconformities and product related Quality processes must become controlled and connected. The OZQA Design & Development QMS Package provides the documentation needed to establish these processes within one practical medical device Quality system.
QMS FOR CONTROLLED DEVICE DEVELOPMENT
Build a Design & Development QMS on your own or with our help.
Moving into formal medical device design and development requires more than technical documentation. Responsibilities, design activities, changes, verification and validation, manufacturing etc. need to operate within a connected quality framework. The OZQA Complete Design & Development QMS combines the foundational quality processes with the additional processes needed to control medical device design and development. Choose whether to customise and implement the system internally or get hands on support from OZQA’s Quality experts.
COMPLETE
DESIGN
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BUILD A QMS
YOURSELF
Build your Design & Development medical device QMS using OZQA’s pre written Quality documentation. Establish a structured foundation that can expand alongside your device.
Ideal for
Medical device companies that need to establish foundational design & development controls, with internal quality resources available for implementation.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
COMPLETE
DESIGN
___
BUILD A QMS
WITH SUPPORT
Start with the same Quality foundation and let OZQA help adapt and implement the system around your organisation and development activities.
Ideal for
Medical device companies that need a complete quality framework for design & development activities with expert support.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
DESIGN & DEVELOPMENT CONTROL
Turn development activities into controlled processes.
As medical device development progresses, technical activities need to operate within a controlled and traceable framework. Design requirements must be defined. Outputs must be documented. Reviews must take place at appropriate stages. Verification and validation must generate objective evidence. Changes must be assessed and controlled. The Design & Development QMS connects these activities with the wider Quality system so that product development does not take place separately from Quality.
MORE THAN DESIGN CONTROL
Control the complete Design & Development process.
Design & Development is not a single procedure. It is a connected process that follows the device from initial requirements through reviews, verification, validation, transfer, manufacturing, changes and CAPA. The QMS should establish clear responsibilities and ensure that the required evidence is created and maintained throughout development.
Your Design & Development QMS should support:
Design & Development Planning
Design Verification & Validation
Design Transfer
Outsourced Manufacturing
Process Validation
Product Acceptance & Release
Identification & Traceability
Nonconforming Product
CAPA
Change Control
Complaints & Product Feedback
Returns
Clinical Evaluation & Investigation
Clinical Safety
The OZQA Design & Development QMS is designed with outsourced and virtual medical device operating models in mind.
ALREADY HAVE A CORE QUALITY SYSTEM?
Add documentation to your existing QMS.
If you already have a quality foundation in place OZQA provides pre-made QMS packages including all SOPs and forms needed to stay compliant. Choose to update your QMS with your own internal personnel or get hands on support from our expert consultants.
ADDITIONS
DESIGN
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UPDATE QMS
YOURSELF
Update your current QMS yourself. Add the processes required to evolve your existing system with 98% pre-written ISO compliant documents.
Ideal for
Companies with an established early stage QMS and internal quality resources available to implement the design package.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
ADDITIONS
DESIGN
___
UPDATE QMS
WITH SUPPORT
Already have a foundational QMS but don't have the resources to implement the documents yourself? Let's help you all the way to ISO compliance.
Ideal for
Companies with an established QMS that need support preparing their organisation for GDP distribution activities.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
FROM DESIGN TO EVIDENCE
Connect your design regulatory requirements.
As the clinical evidence and technical documentation mature, your organisation moves towards demonstrating conformity with the applicable regulatory requirements and preparing the device for the European market. The OZQA Market Access package connects the Quality and product documentation already established with the regulatory activities needed for EU MDR and CE marking.
Bring together the documentation needed to support product safety, ingredients, manufacturing, claims and regulatory compliance. Ensure regulatory, product and Quality documentation is aligned before commercial distribution begins.
BUILT TO WORK TOGETHER
Not just individual templates.
Our products are developed as parts of connected quality processes. Procedures define how the process works and forms capture the required evidence, and related processes connect one document with the wider quality system.
PAPER TO DIGITAL QMS
Use your existing eQMS or let us help you choose one.
The OZQA QMS is system independent. You are not required to purchase a specific software platform to use our documentation. The system can be implemented within an appropriate existing system or eQMS. If you are moving from a simpler setup into a dedicated electronic QMS, OZQA can also help define your requirements and assess suitable solutions. The system should support your quality processes and regulatory responsibilities – not dictate them.
GXP DEVELOPED STANDARDS
Built by life science QA professionals
OZQA combines practical Quality and regulatory experience with ready to implement QMS documentation. Our approach is designed for medical device companies that need a structured and scalable Quality framework without building unnecessary complexity into early development. Whether you are establishing your first Quality processes or preparing to move towards a more comprehensive ISO 13485 QMS, we help you implement the level of Quality management appropriate for where you are today.
 ISO 14971 |  EU IVDR |
|---|---|
 EU MDR |  ISO 13485 |
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CHOOSE WHAT YOU NEED
Three ways to build your QMS.
OZQA provides ready-to-use quality documents, complete QMS packages designed specifically for regulated companies, and expert quality support. Whether you're starting from scratch, improving an existing system or preparing for your next milestone, we help you focus on what actually matters.
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FREQUENTLLY ASKED QUESTIONS
FAQ
Design & Development introduces some of the most important controlled processes within a medical device QMS. When should formal design controls begin? How do verification and validation differ? How should Risk Management connect with design activities?
The right setup depends on your device, organisation and development stage. The Design & Development QMS provides a structured framework that can be adapted to the activities your organisation actually performs.