Market Access QMS Package
Moving from development to commercialisation introduces new regulatory and operational responsibilities. Technical Documentation must be maintained, conformity assessment activities coordinated, registrations controlled and distribution activities established. The OZQA Market Access QMS Package expands your Design & Development QMS with the processes needed to support CE marking and controlled market introduction in the EU.
QMS FOR MEDICAL DEVICE MARKET ACCESS
Build a Market Access QMS on your own or with our help.
Regulatory responsibilities, conformity assessment, registrations, external regulatory partners and commercial distribution activities need to connect with the Quality system already established around your device. The OZQA Market Access QMS provides a practical framework for managing these responsibilities while allowing specialist regulatory, logistics and other operational activities to remain outsourced. Choose whether to customise and implement the system internally or get hands on support from OZQA’s Quality experts.
COMPLETE
MARKET ACCES
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BUILD A QMS
YOURSELF
Build your 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 preparing for CE marking and commercialisation with internal quality resources available to customise and implement the QMS.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
COMPLETE
MARKET ACCES
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BUILD A QMS
WITH SUPPORT
Start with pre-built quality foundation and let OZQA help adapt and implement the system around your organisation and development activities.
Ideal for
Medical device companies preparing for market entry that need a complete quality framework and support adapting it to their device, organisation and outsourced operating model.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
FROM DEVELOPMENT TO COMMERCIALISATION
Prepare your medical device QMS for market entry.
Your Design & Development QMS establishes control over the device, its development, outsourced manufacturing, validation and clinical evidence. Market Access adds the processes needed to translate this foundation into a controlled commercial product. Technical Documentation, regulatory requirements, conformity assessment, registrations and distribution activities should remain connected with Design, Risk Management, Supplier Management and Change Control. The OZQA Market Access package provides the next layer of your QMS as your organisation prepares to place its device on the market.
FROM DEVICE DOCUMENTATION TO CE MARKING
Control your regulatory pathway.
CE marking is not a standalone Quality process. It is the result of demonstrating that the device and the systems supporting it meet the applicable regulatory requirements. Your QMS should define how regulatory requirements are identified, responsibilities are assigned, Technical Documentation is maintained and regulatory activities are reviewed and controlled.
Your Market Access medical device QMS should support:
Regulatory Strategy & Requirements
Technical Documentation
General Safety and Performance Requirements
Conformity Assessment
Declaration of Conformity & CE Marking
UDI & Device Registration
Regulatory Changes
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
MARKET ACCES
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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 and compliant documents.
Ideal for
Companies with an established QMS and internal quality resources available to implement the market access package.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
ADDITIONS
MARKET ACCES
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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 compliance.
Ideal for
Companies with an established QMS that need support preparing their organisation for market access.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
AFTER MARKET ENTRY
Move from market access to ongoing product oversight.
Placing a medical device on the market introduces an ongoing responsibility to monitor its safety, performance and Quality. The OZQA Post Market QMS Package adds the processes needed to collect and evaluate information from the market, identify emerging issues and maintain appropriate regulatory oversight throughout the commercial lifecycle.
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 |
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 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
Preparing a medical device for the market creates new Quality and regulatory questions. When should Technical Documentation be finalised? Which regulatory activities can be outsourced? How should a Notified Body relationship be managed? What controls are needed when warehousing and logistics are outsourced?
The right setup depends on your device, classification, conformity assessment route, supply chain and commercial model. The OZQA Market Access QMS provides a structured framework that can be adapted to the regulatory and distribution responsibilities your organisation actually holds.