Post Market Surveillance Quiz

What is the main purpose of the Post-Market Surveillance (PMS) system at Teleflex?

• To monitor sales performance

• To ensure compliance with international PMS planning and reporting requirements

• To develop new marketing strategies

What kind of devices require a Post-Market Surveillance Report (PMSR)?

• Class I devices

• Class IIa devices

• Class III devices

What document is required for manufacturers of Class IIb and Class III devices under EU Medical Device Regulation (MDR)?

• PMS Plan

• PSUR (Periodic Safety Update Report)

• Sales Report

Who is responsible for creating and maintaining the PMS plan?

• Business Unit Quality Engineering (QE)/Design Assurance (DA)

• Marketing Team

• Finance Department

How often should a PMS plan be reviewed or updated for a Class II device in the U.S. FDA regulation?

• Every 3-5 years

• Annually

• Every 2 years

What kind of information is typically included in a Clinical Evaluation Report (CER)?

• Financial reports

• Sales data from multiple regions

• Clinical evidence, risks, and benefits of the device

What does CAPA stand for in PMS documentation?

• Corrective and Preventive Action

• Clinical and Product Analysis

• Compliance and Performance Assessment

In Canada, how often must manufacturers of Class III medical devices assess new information for the device?

• Every 5 years

• Every 24 months

• Annually

What is the key role of Post-Market Clinical Follow-up (PMCF)?

• To monitor the financial growth of a product

• To gather clinical data to update risk assessments and clinical evaluations

• To improve advertising campaigns

Which department provides feedback regarding off-label use of medical devices?

• Marketing

• CMA Medical Communications

• Legal