Medical Device Industry
An early stage medtech company does not need the same Quality Management System as a company approching market access. But the foundations established early can determine how easily the quality system can scale as responsibilities, outsourced activities and regulatory requirements increase.
MEDICAL DEVICE QUALITY MANAGEMENT
Quality Management for Medical Device Companies
Medical device development requires Quality Management throughout the product lifecycle. From establishing the first Quality processes to Design & Development, regulatory market access and Post Market Surveillance, the Quality Management System needs to develop alongside the device and the organisation behind it.
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.
FROM DEVELOPMENT TO MARKET
One medical device lifecycle. Changing quality responsibilities.
A Medical Device Quality Management System, or QMS, is the framework of processes, responsibilities, procedures and records used to ensure that medical devices are developed, manufactured and maintained under controlled conditions. For many medical device companies, ISO 13485 provides the central framework for establishing this system.
BUILD THE QUALITY FOUNDATION
Early Stage quality management.
Quality Management should begin before the organisation reaches formal regulatory submission or commercial manufacturing. During early development, the objective is not necessarily to establish every procedure that may eventually be required. Instead, the organisation needs a controlled foundation that can support increasingly regulated activities as development progresses.
FROM IDEA TO MEDICAL DEVICE PRODUCT
Quality management for design & development.
As the product moves into structured Design & Development, the QMS becomes increasingly device specific. Requirements need to be defined. Design outputs need to be controlled. Verification and validation need to demonstrate that the device has been developed as intended. Changes need to be assessed and documented. For medical device companies that outsource manufacturing and other specialised activities, the QMS also needs to establish how those activities remain appropriately controlled.
PREPARING FOR COMMERCIAL RESPONSIBILITIES
Market access quality management.
The transition from design & development to market access changes the Quality landscape again. The organisation is no longer only managing development and clinical sponsor responsibilities. It must prepare for the obligations associated with placing a medical device product on the market.
Moving from development to market access requires the Quality system, product documentation and regulatory strategy to come together.Under the EU Medical Device Regulation, manufacturers need to demonstrate that applicable requirements have been addressed before a device is placed on the market.
MONITORING POST MARKET ARCTIVITIES
Quality management for post market.
Placing a medical device on the market does not complete the regulatory lifecycle. Manufacturers need to systematically collect and evaluate information about the Quality, safety and performance of their devices during real world use.
The extent and frequency of these activities depend on the device and applicable regulatory requirements. Importantly, Post Market Surveillance should not operate as an isolated reporting system. The information collected needs to feed back into the wider QMS.
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.
The 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 medical device QMS requirements, development, compliance, outsourcing and Quality Management from early stage through to commercialisation.