Regulatory Affairs Exam

What is a medical device?

A device used in humans for diagnosis, monitoring or treatment that does not act via pharmacological, immunological, or metabolic means.

What is an in vitro diagnostic (IVD) device?

A medical device used outside the body to examine human samples for diagnostic purposes

Give examples of IVDs

Reagents, test kits are used to analyse samples

What is ISO?

International Organisation that develops standards to ensure quality, safety, and efficiency

What is ISO 9001?

General Quality Management System (QMS) standard

What is ISO 13485?

QMS standard specifically for medical devices, ensuring regulatory compliance

Key difference between ISO 9001 and ISO 13485

• ISO 9001 → general quality

• ISO 13485 → medical device-specific requirements

What is the purpose of ISO 13485?

Ensure organisations consistently produce safe and effective medical devices

Why is ISO 13485 important?

• Ensures regulatory compliance

• Improves product safety

State 2 benefits of ISO 13485 accreditation

• Improved patient safety

• Continuous improvement of QMS

What is a Quality Management System (QMS)?

A system of documents, processes, and procedures ensuring consistent product quality

Purpose of a QMS (CRC)

Ensure processes are:

• Consistent

• Repeatable

• Controlled

Why is documentation important in QMS?

Ensures processes are understood, standardised, and auditable

What does Clause 4 cover?

Documentation and QMS structure

What does Clause 5 cover?

Management responsibility

What does Clause 6 cover?

Resource management

What does Clause 7 cover?

Product realisation (design → manufacture)

What does Clause 8 cover?

Measurement, analysis, and improvement

What is a quality manual?

Document outlining scope, processes, and structure of QMS

What is a quality policy?

Statement of commitment to quality and continuous improvement

What are quality objectives?

Measurable goals (SMART) to improve quality

Is ISO 13485 legally required?

No, but it supports compliance with regulations (e.g. MHRA)

How does ISO 13485 relate to CE marking?

Helps demonstrate compliance for medical device approval

Why is risk management important in ISO 13485?

Minimises harm to patients and ensures product reliability

What determines if something is a medical device?

The intended purpose defined by the manufacturer

Why are medical devices not considered medicines?

They do not achieve their main effect via pharmacological, immunological or metabolic action

What stages of lifecycle does ISO 13485 cover? (DDPSDS)

• design

• development

• production

• storage

• distribution

• servicing

What does ISO 13485 demonstrate to regulators?

Ability to consistently meet regulatory and customer requirements

Why must QMS processes be simple?

To ensure they are understood, repeatable, and consistently followed

Why are ISO 13485 clauses important?

They structure the QMS to ensure full regulatory compliance across lifecycle