Week 5 medical device standards part 2

Question 1

Describe the medical device manufacturing sector

Answer 1

Very regulated sectors whereby significant-quality systems and product requirements must be passed

Question 2

Why must the manufacturing sector be welled regulated

Answer 2

They are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose

Question 3

What is a quality management system?

Answer 3

A structured system of an organization’s consisting of policies, procedures, and processes

Question 4

what about the system of quality management

Answer 4

It is structured and integrated

Question 5

What is the purpose of a quality management system?

Answer 5

To achieve quality, mission vision, goals, and objectives of the organization

Question 6

How do they achive the “purpose of quality management system”

Answer 6

By simplifying, Being transparent through clarity of procedures , lastly, by controlling the whole system so it can function properly

Question 7

Describe the application of simplify and clarity

Answer 7

clarity in communications on roles and responsibilities and processes between
•Managment
•Staff - in their roles and responsibilities
•Suppliers
•Customers

Question 8

What will be achieve by having good control procedure in QMS

Answer 8

• Effectient processes

* Effective processes

Question 9

What will efficent processes and effecitve processes result in ?

Answer 9

Having consistency in
•Quality
•Products and services
•Prompy detection and correction of defects leading to continued improvement of product and services
This all will also result in less wastage, thereby cutting costs, increase productivity and better business and profits

Question 10

What is a medical device quality managment system

Answer 10

Medical device quality management system (QMS) is a structured system 
•Of procedure and processes 
•For all aspects of design 
•Manufacturing 
•Supplier management, risk management 
•Complaint handling 
•Clinical data
•Storage 
•Distribution 
•Product labeling

Question 11

Describe the regulatory requirment for medical devie QMS

Answer 11

International regulations for MD QMS will need implementation and maintenance of a quality management system as a condition of product registration.

Question 12

Device that manufacturered in which country follows the ISo 13485 standards

Answer 12

Europe and many other countries

Question 13

What regualtion does the US follow

Answer 13

US FDA’s Quality system regulation (QSR)

Question 14

In what condtions must company complied with the US FDA quality system regulation

Answer 14

• Should they be US medical device companies that supply internationally
• Should they be companies that are outside US that want to distribute products In the us

Question 15

What are the important points in ISO

Answer 15

• Scope
• Managment responsibilities
• Corrective and preventive actions
• Software validation
• Supply chain
• Outsourcing
• Risk management
• Post market information gathering
• Adverse event reporting
• Design verification and design validation
• Compliant handling
• Handling of retured product
• Environmental controls
• Process validation

Question 16

Describe iso important points in terms of scope

Answer 16

• Focus on QMS requirements, not products requirements
• QMS requirements in standard apply throughout the life cycle of the product design, developed, manufactured, distributed