MCT Context of the organization T 18

1. Internal issues that may affect the company's performance are, among others:

• Technology environment
• Economic environment
• Products and services
• Corporate culture

1. The characteristics of a MD, relating to safety, concern:

• How the MD works
• Inteded use
• Reasonably foreseeable misuse
• Materials in contact with the patient
• User error

2. External issues that may affect the company's performance are, among others:

• Social environment
• Regulatory environment
• Corporate culture
• Products and services

2. The quantitative risk assessment appeared over the years:

• 1650
• 1792
• 2004
• 2009

3. Examples of interested parties:

• Law and regulations
• Customers
• Stockholders
• Neighbours

3. To evaluate the risks related to the saety of the medical device after the start of marketing:

• A risk management plan is used
• A production information collection system is used
• A system for collecting post-production information is used
• A production information review system is used
• A post-production information review system is used
• A post-market monitoring plan is used

4. Anticipating the needs and expectations of workers is:

• Identifying and reduce OH&S hazards
• Using SWOT analysis
• Preparing to address risks
• Seizing opportunities for improvement

4. Risk reduction is confirmed by:

• Checking the implementation of the control measure
• Verifying the effectiveness of the control measure
• Carrying out tests with users
• Recording the results of veryfying the effectiveness of control measures

5. The number of requirements of ISO 45001 version 2018 is:

• Less than 200
• Over 200
• Over 300
• Less than 300

5. The risk analysis takes into account:

• The impact of risk
• The likelihood of the risk occurring
• Risk control measures
• The root causes of risk
• Interaction with other risks