Medical Device QMS Packages
The Quality Management System required for a medical device organisation depends on what the company does, what it outsources and where the product is in development. OZQA's medical device QMS Packages are split and designed for every regulatory step. Reduce time, unnecessary resources and build a QMS appropriate to where your organisation is.
QUALITY THROUGHOUT THE LIFECYCLE
Quality for medical device companies.
OZQA Medical Device QMS Packages provide structured Quality documentation for companies moving from early development through Design & Development, Market Access and Post Market activities. Start with the Quality foundation you need today and expand the same QMS as your device, organisation and regulatory responsibilities develop.
BUILD THE QUALITY FOUNDATION
Early Stage quality management.
The Early Stage QMS is designed for medical device companies that need to establish a structured Quality foundation before implementing the broader processes required for device development and commercialisation.
COMPLETE
EARLY STAGE
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BUILD A QMS
YOURSELF
Build your first medical device QMS using OZQA’s pre written Quality documentation. Establish a structured foundation that can expand alongside your device.
Ideal for
Early stage medical device companies with internal Quality resources available to customise and implement the QMS.
Package Includes
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Pre-written SOP's
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Ready to use log forms
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Step-by-step QMS guide
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Implementation action log
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24/7 AI quality support
BUILD QUALITY AROUND YOUR DEVICE
Design & Develop quality management.
As development progresses, the QMS needs to expand from organisational controls into processes that directly govern the device. The Design & Development QMS builds on the Early Stage foundation and adds the Quality processes needed to control development, verification and validation, outsourced manufacturing, Quality events and clinical evidence.
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
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Pre-written SOP's
-
Ready to use log forms
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Step-by-step QMS guide
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Implementation action log
-
24/7 AI quality support
FROM DEVELOPMENT TO THE MARKET
Market Access quality management.
Market Access brings together the Quality, regulatory and operational processes needed to move a developed medical device towards the European market.
The Market Access QMS builds on the Design & Development system and adds the framework needed to support conformity assessment, CE marking, registration and controlled commercial distribution.
COMPLETE
MARKET ACCESS
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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
-
Ready to use log forms
-
Step-by-step QMS guide
-
Implementation action log
-
24/7 AI quality support
MONITORING THE COMMERCIAL LIFECYCLE
Post Market quality management.
Once a medical device enters the market, the manufacturer needs to systematically collect and evaluate information about its Quality, safety and performance.
The Post Market QMS provides the processes needed to manage these activities and connect new information back into the existing Quality system.
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
-
Ready to use log forms
-
Step-by-step QMS guide
-
Implementation action log
-
24/7 AI quality support
QUALITY OVERSIGHT ACROSS YOUR PARTNER NETWORK
Managing quality in virtual medical device companies.
Modern medical device and medtech companies can operate with surprisingly little infrastructure in house. Development, clinical trials, manufacturing, testing, storage, distribution and post market surveillance can all involve external specialists. This makes supplier and partner oversight a central part of the medical device QMS.
Quality Agreements, qualification, risk assessment, audits, performance monitoring, deviations, CAPAs, changes and documented oversight help establish how responsibilities are controlled across the external network.
The principle is important: Activities can be outsourced. Oversight cannot simply disappear!
ISO STANDARDS THROUGHOUT THE LIFECYCLE
Medical device quality regulations.
ISO 13485 provides an internationally recognised framework for Quality Management Systems within the medical device industry.
Regulation (EU) 2017/745 establishes the regulatory framework for medical devices placed on the European Union market.
For organisations outsourcing significant operational activities, the QMS should clearly distinguish between processes performed internally and activities performed by external providers.
For manufacturers, EU MDR connects the Quality Management System with product specific regulatory requirements throughout the device lifecycle.
ISO 14971 provides the framework for identifying hazards, estimating and evaluating associated risks, implementing risk controls and monitoring the effectiveness of those controls throughout the medical device lifecycle.
START WHERE YOU ARE
Three ways to build a better QMS.
The OZQA QMS 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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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 QMS.
FROM PROCEDURES TO WORKFLOWS
Medical device QMS digitalisation.
Your medical device QMS may be paper based, document based or implemented within a digital Quality Management System. The technology itself does not determine compliance.
The underlying processes, responsibilities, controls, records and oversight need to be appropriate for their intended use. For computerised systems, requirements around fitness for purpose, security, audit trails and proportionate risk based validation. Digitalisation can nevertheless make a well designed QMS easier to operate by connecting activities
FREQUENTLLY ASKED QUESTIONS
FAQ
Medical device Quality Management can look very different depending on your organisation, development stage and regulatory responsibilities. Here, we answer some of the most common questions about pharmaceutical QMS requirements, compliance, outsourcing and Quality Management from early stage through to commercialisation.