Post Market QMS Package
Build the Quality framework for your device after market entry. Placing a medical device on the market is the beginning of an ongoing Quality and regulatory responsibility. Information from customers, complaints, incidents, clinical experience and other Post Market sources must be collected, evaluated and used to maintain the safety, performance and regulatory compliance of the device. The OZQA Post Market QMS Package adds the processes needed to monitor your device throughout its commercial lifecycle and connect Post Market information with the wider Quality system.
QMS FOR COMMERCIAL MEDICAL DEVICES
Build a Post Market QMS on your own or with our help.
Once your device enters the market, your QMS needs to actively collect and evaluate information about how the product performs in real world use. Complaints need to be assessed. Incidents may require regulatory reporting. PMS data needs to be reviewed. Clinical evidence and Risk Management need to remain current. Where necessary, corrective actions or Field Safety Corrective Actions must be initiated. The OZQA Post Market QMS brings these activities together within one connected Quality framework.
COMPLETE
POST MARKET
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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 manufacturers entering or operating in the European market 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
POST MARKET
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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 that need a complete quality framework for post market 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
FROM MARKET ENTRY TO LIFECYCLE OVERSIGHT
Quality continues after CE marking.
CE marking does not complete the Quality lifecycle. Once a device is placed on the market, the manufacturer needs a systematic process for collecting and evaluating information about its Quality, safety and performance. Post Market information should not remain isolated within PMS reports or complaint records. Relevant findings need to feed back into Risk Management, Clinical Evaluation, CAPA, Design & Development and the Technical Documentation. The OZQA Post Market QMS establishes the processes needed to create this continuous feedback loop.
MONITOR YOUR DEVICE IN REAL WORLD USE
Turn Post Market information into Quality oversight.
Post Market Surveillance provides the structured framework for collecting, recording and analysing information about devices throughout their commercial lifecycle. Your QMS should define what information is collected, where it comes from, how it is evaluated, who reviews it and when findings require further action.
Your Post Market QMS should support:
PMS Planning
PMS Data Collection
PMS Evaluation
PMS Reporting
Feedback into the QMS
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
POST MARKET
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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 QMS and internal quality resources available to implement the post market package.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
ADDITIONS
POST MARKET
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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 ISO compliance.
Ideal for
Companies with an established QMS that need support preparing their organisation for post market activities.
Package Includes
Pre-written SOP's
Pre-written work instructions
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
ONE QMS ACROSS THE DEVICE LIFECYCLE
From early development to market oversight.
The Post Market package completes the OZQA medical device QMS framework. Each stage builds on the Quality processes established before it rather than replacing them. The result is one connected Quality system that develops alongside your device.
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
Post Market responsibilities begin when your device enters the market, but the processes supporting them need to be ready before launch. What is the difference between PMS and vigilance? When is PMCF required? How should complaints be assessed? Which events need regulatory reporting? And what can be outsourced while remaining compliant?
The right Post Market setup depends on your device, classification, risks, clinical evidence and commercial model. The OZQA Post Market QMS provides a structured framework for maintaining oversight of these activities throughout the commercial lifecycle.