Lecture 9 Flashcards
what is quality assurance? 6 aspects
involves systematic processes to ensure that medical devices meet regulatory standards, perform reliably, and are safe for patient use.
1) regulatory compliance
2) risk management
3) design verification and validation
4) process verification and validation
5) post market surveillance
6) continuous improvement
give one aspect of regulatory compliance and its structure
manufacturer has to ensure that the quality management system is implemented.
Documentation
Management
Resources
Product realisation
Measurement, analysis, improvement
difference between design verification and validation? what does a suitable verification method have to be? most common sample size used?
verification = does the product meet the requirements. Method has to be sth we can measure.
validation = are our requirements the correct ones.
most used is 95% error free on a 95% confidence level
difference between process verification and validation (give an example)
verification = ensures ongoing consistency in an established process, confirming it meets specifications during production (ex dimension measurements)
validation = demonstrates that a process reliably produces products that meet quality and safety standards, typically done before or at the start of production (mechanical properties testing)
what are the three qualifications in process validation?
IQ = installation qualification
OQ = operational qualification
PQ = performance qualification
examples of IQ
equipment verification
environmental conditions
utilities (verify connections)
documentation
safety features (confirm alarms are functional f.ex)
examples of OQ
functionality testing (components work as expected)
control settings
alarm verification
calibration checks
operational procedures
-> min/max parameter testing
examples of PQ
full scale testing (real production conditions)
consistency checks
stress testing
product quality
operator training verification
what is a non conformity incident (NCI)
when a device fails to meet safety or quality standards, potentially compromising patient safety or effectiveness, requiring investigation and corrective action
what is a CAPA? what are common triggers?
CAPA = corrective and preventive action
- NCI
- customer complaints or adverse event reports
- audit findings or regulatory inspections revealing deficiencies
- trending data indicating recurring issues
- internal quality control failures
what is the different steps in continuous improvement - change
- design or process change request
- review and approval
- risk and QRA review
- design or process change validation
- document changes and approvals
