Regulations and ethics for medical device development

Question 1

What is a medical device?

Answer 1

Is any instrument, appliance, etc that is intended by the manufacturer to be used alone or in combination for a medical purpose.

Question 2

List the basic principles of the declaration of Helsinki (Ethical principles)

Answer 2

1)Right of the individual - fully inform patient so they can consent

2)The research goal can never take precedence over the rights and interests of the individual research subjects

3)Medical research on humans may only be done if the importance of the objective outweighs the risk

4)Consent on a surrogate must be obtained if the subject is considered vulnerable (their consent must be obtained aswell

Question 3

What are the 3 steps to develop a medical device?

Answer 3

step 1 - Research project
step 2 - Product commercialisation
step 3 - Regulations