Mindset XR Module 4: What is quality assurance?

Welcome to the Mindset Extended Reality (XR) for digital mental health programme learning resources, which include three series: medical regulation, clinical evidence and lived experience involvement. Mindset-XR is helping to catalyse the growth of immersive digital mental health solutions in the UK, through funding, tailored support and training. It is delivered by Innovate UK and the Health Innovation Network South London (HIN).

This series focuses on medical regulation, with key insights from Hardian Health. Across 10 modules, we provide an accessible introduction to people and companies that want to learn more about medical device regulation, with a focus on XR devices. Each module offers a high level overview of a different topic, including medical device regulation in the UK and EU, core medical device standards and overseas regulation. Each module includes additional resources to support your learning and a quiz to test your understanding.

Outline

Welcome to Module 4: Quality Assurance. In this section, we're exploring how to apply quality assurance to the development of medical device software and hardware.

What is quality assurance and why should I apply it?

The definition of Quality Assurance and why it is applied.

How do I apply quality assurance?

The role of quality management systems for tracking Quality Assurance.

When should I apply quality assurance?

When to apply for Quality Assurance, who needs to apply and where is it applied.

Quiz

Multiple choice questions to test your understanding of Quality Assurance.

What is quality assurance and why should I apply it?

To kick off, let’s discuss what is meant by the term quality assurance. It may mean different things to different people, but for the purposes of this discussion it has a formal definition:

Quality Assurance: part of quality management focused on providing confidence that quality requirements will be fulfilled
International Standard ISO 9000:2015 Quality management systems - Fundamentals and vocabulary

Quality Management: coordinated activities to direct and control an organisation with regard to quality
International Standard ISO 9000:2015 Quality management systems - Fundamentals and vocabulary

Quality: degree to which a set of inherent characteristics fulfils requirements

Characteristic: distinguishing feature

Requirement: need or expectation that is stated, generally implied or obligatory

So let’s put all that together in the context of medical devices, which is what this series of modules is about, and considering that you’ve already heard in previous modules about the obligation of manufacturers to meet the regulatory requirements for medical devices.

Quality assurance: the part of [the set of] coordinated activities to direct and control an organisation with regards to [the] degree to which a set of distinguishing features [of the medical device] fulfils the needs or expectation that is [set out in applicable medical device regulations, to assure that medical devices are safe, effective and cybersecure].

So, what is the organisation and what activities must it coordinate, particularly in the development and deployment of the XR tools that this module is particularly interested in?

The organisation we are talking about is the medical device manufacturer. Manufacturer itself is a term with a formal, legal, definition. Let’s use the one from the UK Medical Device Regulations (MDR) as it comprehensively illustrates a number of key points:

“manufacturer” means:

the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or
the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or

Noting that the word person in this context is shorthand for natural or legal person, that is an actual human person or a company with the given responsibilities - generally being a limited liability company, for various legal reasons - these are the key points:

If your company develops and/ or deploys software with a medical purpose and labels it with your company name (or indeed your own name as a natural person) then you are a medical device manufacturer.

Note that each NHS Trust is in effect a company in its own right, with the same manufacturing responsibilities as a commercial company. Universities are in the same position of having the same responsibilities if they put their badge or logo on a medical device.

If your company (or NHS Trust, or University) develops and/ or deploys software built by another company, or by subcontracted individuals, and labels it with your company name then you are a medical device manufacturer.

And if you put your logo or badge on supporting hardware, for example AR glasses, you are now the manufacturer of the hardware.

If you install custom software that gives a medical purpose to these glasses, and prevents any other purpose that the glasses could be used for, then you are now also the manufacturer of the hardware. If however you install an app with a medical purpose on the glasses and that app can be used just like a range of other apps that are installed on the glasses, and the glasses remain badged for their original manufacturer, then only your app is a medical device.

Now we know what the organisation is, what are the activities? At the highest level, we need to coordinate three life cycles:

The clinical development lifecycle (CDLC)
Learn more in module 6.
The product or software technical development lifecycle (PDLC or SDLC)
Learn more in module 8.
Risk management throughout the life cycles

Quality assurance is then applied to coordinate these three life cycles, along with the other activities needed to run an effective company.

How do I apply quality assurance?

Quality assurance is typically applied through the establishment and use of a Quality Management System (QMS).

A QMS has its own definition in ISO 9000 - actually, four definitions: quality, system, quality assurance and management system.

These can be merged as follows:

Quality Management System (QMS): a set of interrelated and interacting elements to establish policy and objectives and to achieve those objectives to direct and control an organisation with regard to degree to which a set of distinguishing features [of the medical device] fulfils the needs or expectation that is [set out in applicable medical device regulations, to assure that medical devices are safe, effective and cybersecure].

You will be introduced to the international standard ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes in Module 5.

We use this standard to set the content of the QMS into a Quality Manual and a set of around 20 procedures. The three key procedures for development and deployment of safe, effective and cyber secure medical device software and hardware are:

Design Control Procedure
Clinical Evaluation Procedure
Risk Management Procedure

The Design Control Procedure governs the Product Development Life Cycle (PDLC) or Software Development Life Cycle (SDLC), splitting it into a series of logical phases:

Planning

Design input

Design output

Design verification

Design validation

Design transfer

The Design Control Procedure also covers:

Design review

Control of change

Documentation (design and development files)

Identification and traceability

We’ll cover these phases in more detail in Module 8, when we discuss what standards should be used and how to apply them, along with risk management and how this all interacts with the concepts of clinical evaluation that are covered Module 6 and Module 7.

When should I apply quality assurance?

You should start to apply quality assurance when you start to translate research into development. This is when the possibly divergent ideas for a technological solution to a problem start to converge into a product idea. We apply a Technology Readiness Level (TRL) scale to self-assess this:

As Quality Management System (QMS) is about running an effective organisation, everyone in the organisation is touched by and touches the Quality Management System and therefore plays a part in quality assurance.

This extends to any subcontractors you use to help develop your technology, any suppliers you buy hardware from - even your web host and any app store are suppliers that can impact the quality of your devices so need to form part of your Quality Assurance through your Quality Management System.

Summary

In this module, Quality Assurance, we looked at the definition of Quality Assurance and how it is applied. We also explored the role of quality management systems and who needs to apply for Quality Assurance. After using this resource, you should have a understanding of the following:

Quality assurance covers coordinated activities to direct and control an organisation with regards to the degree to which a medical device is developed and deployed to be safe, effective and cybersecure.

The key activities to be coordinated are design control, clinical evaluation and risk management.

Design control, clinical evaluation and risk management really need to start once a research idea starts to be translated into a product development.

Quiz

Quality Assurance

It's time to test your knowledge of applying quality assurance to medical devices!

1 / 3

Quality Assurance does not apply to basic research

False

True

2 / 3

What is Quality Assurance in medical devices?

Making your software or hardware device look smart and feel substantial to your customers.

The coordinated effort for your company to make your device safe, effective and cybersecure.

3 / 3

Which part of your organisation is responsible for Quality Assurance?

Everyone in the organisation

Your Quality Assurance Manager

Government agencies

Hired consultants

Your score is

Got questions, comments or feedback?

Get in touch with the team

hin.mindset@nhs.net | mike@hardianhealth.com

Mindset XR Module 4: What is quality assurance?

Outline

What is quality assurance and why should I apply it?

Organisation

“manufacturer” means:

Activities

The clinical development lifecycle (CDLC)

The product or software technical development lifecycle (PDLC or SDLC)

Risk management throughout the life cycles

How do I apply quality assurance?

Quality Management Systems: Requirements for regulatory purposes

Design Control Procedure

Clinical Evaluation Procedure

Risk Management Procedure

When should I apply quality assurance?

Technology Readiness Level (TRL)

Who needs Quality Assurance and where is it to be applied?

Summary

Quiz

PowerPoint: Quality Assurance - click to download