Chapter 6 Software

Question 1

What is that IEC standard for Medical Device Software

Answer 1

IEC 62304

Question 2

Stand alone—- can also be a medical device

Answer 2

Software

Question 3

——— are medical devices according to FDA, whereas

they may not be under the European MEDDEV 2.1/6 guidance

Answer 3

MDDS (Medical Device Data Systems)

Question 4

Not all ——- Software used within healthcare can be qualified as a medical device

Answer 4

Stand alone

Question 5

——- guidance says stand alone software as a medical device contains two convenient decision trees for determining whether first, the software constitutes a medical device, and subsquently, whether the medical device is
regulated under MDD or IVDD

Answer 5

MEDDEV 2.1/6

Question 6

Unlike the EU Directives, —– require computer systems used to create. modify and maintain electronic
records and manage electronic signatures to be subject to validation requirements.

Answer 6

US regulations

Question 7

The software validation guidance discusses general validation principles that —- considers applicable to validating medical device software or the software used to design, develop or manufacture medical devices.

Answer 7

FDA

Question 8

FDA exempts—–from pre-market notification requirements

Answer 8

MDDS

Question 9

The EU ——– is a new data security regulation that took affect effect 25 may 2018

Answer 9

GDPR (General Data Protection regulation)

Question 10

Mobile Medical Applications— FDA or EU Guidance?

Answer 10

Guidance for Industry and Food and Drug Administration Staff