Lecture 2

Question 1

explain the steps in the product development process - V model

Answer 1

• user needs (intended use)
• design input: functions and features
• design output: drawings
• process input: production concept and requirements
• process output
• process verification and validation
• design verification: is the device meeting the requirements?
• design validation: have we defined the right requirements?

Question 2

risk management: 3 types of risks

Answer 2

application risks, design risks, production risks

Question 3

examples of safety and performance requirements

Answer 3

safety:
- biocompatibility
- cleaning and sterilisation validation

performance:
- mechanical prop. of device
- design accuracy
- packaging

Question 4

manufacturing process requirements

Answer 4

general:
- process qualification / validation
- process management (changes)
- training
- material handling
- supplier management
- maintenance

equipment / material / personnel:
- surgical planning software
- 3D printer
- post processing tools
- QA instruments
- operating personnel