Medical Device

Which of the below is totally new in clause 4?

• Medical device file

• Control of document

• Control of Records

• Quality manual

Which are the following not a part of the quality objective?

• Relevant function and level

• Regulatory requirements

• Product requirements

• Company requirements

What is the clause number for management review?

• 5.5

• 5.6

• 5.4

• 5.1

What is the title of clause 6.4?

• Work environment

• contamination control

• Work environment and contamination control

• Infrastructure

What is the criteria for risk?

• Meeting regulatory requirements

• Usage of medical device

• Safety of Medical Device

• Performance of medical device

Records shall be

• Stored

• photocopy

• Retrieved

• Retained

Which clause applicable to you?

• 7.5.3 installation activities

• 7.5.4 servicing activities

• 7.5.6 particular requirements for sterile medical devices

• 7.1 planning of product realization

Supplier shall be

• Interviewed

• evaluated

• selected

• Re-evaluated

Production shall be

• Planned

• Monitored

• Carried out

• Controlled

Records shall be retained

• not less than two years from

  the medical device release by the organization.

• at least the lifetime of the medical device as defined by the

  organization,

• Specified by regulatory

• not less than two years from

  the medical device manufactured by the organization.