Lecture 9

Question 1

What is quality assurance?

Answer 1

Systematic processes to ensure that medical devices
- meet regulatory standards
- perform reliably
- are safe for patient use

Question 2

Aspects of quality assurance

Answer 2

• Regulatory compliance
• Risk management (ISO 14971)
• Design verification adn validation
• Process verification and validation
• Post market surveilance
• Continous improvement

Question 3

What are the components of the risk management overview?

Answer 3

• Application risks (they derive design risks)
• Design risks (reduction of these induce production risks)
• Production risks

Question 4

What design verification?

Answer 4

Is the device meeting our requirements?
(when making design verfication questions, it’s important for them to be as simple as possible)

Question 5

What is design validation?

Answer 5

Have the correct requirements been identified?

Question 6

What is the example process requirements of a cranial implant?

Answer 6

1. Implant design
2. Printing & Post-processing
3. Cleaning, packaging and labelling
4. Sterilisation

• Throughout, the product/design requirements feed into and direct everything

Question 7

What is process verification?

Answer 7

Process Verification:
- Ensures ongoing consistency in an established process, confirming it meets specifications during produciton

E.g. dimensions measurement

Question 8

What is process validation?

Answer 8

Process validation:
- Demonstates that a process reliably produces products that meet quality and safety standards, typically done before or at the start of production
(Done BEFORE final product is produced)

E.g. mechanical propoerties (e.g. tensile strength)

Question 9

What are the 3 parts of process validation?

Answer 9

• Installation qualification (IQ)
• Operational Qualification (OQ)
• Performance qualification (PQ)

Question 10

What is Installation qualification (IQ)?

Answer 10

Verifies that equipment is installed correctly and in compliance with design specifications, manufacturer recommendations, and regulatory requirements.

• Delivered as specified
• Ensure proper installation
• Verify documentation (e.g. manuals)
• Recording environmental conditions (e.g. humidity)

Question 11

What is Operational Qualification (OQ)?

Answer 11

Confirms that the equipment operates as intended under controlled conditions.

• Testing individual functions of the equipment
• Conducting calibration checks
• Documenting deviations

Question 12

What is Performance qualification (PQ)?

Answer 12

Ensures that the equipment performs effectively and reproducibly under real-world operating conditions.

• Running the equipment with actual process materials.
• Testing equipment performance under normal and worst-case scenarios.
• Collecting data to demonstrate consistency and reliability.

Question 13

What is a non-conformity incident?

Answer 13

(Occurs in the post market surveillance)
Is when a medical device fails to meet safety or quality standards

Question 14

What is Corrective and Preventativve action (CAPA)?

Answer 14

Refers to continous improvement.
It is triggered by events indicating potential or actual issues with product quality, safety, or compliance.

Common triggers:
- Non-conformity incident
- Customer complaints or adverse event reports
- Audit findings
- Trending data indicating recurring issues
- Internal quality ocntrol failures

Question 15

What is the continous improvement - change process?

Answer 15

1. Design* change request
2. Change review & approval
3. Risk & QRA review
4. Design* change & validation
5. Document changes & approvals

*and/or process change