Module 16 2022

05/09/2022

Examples of common mistakes

Not having an appropriate Post Market Surveillance Plan or not executing an approved plan

We have a PMS Procedure, that’s enough, right? We log every complaint, is that good enough? How much PMS should I be doing?

The Organisation for Professionals in Regulatory Affairs

21

Typical Non Conformities relating to PMS

• Manufacture provides summary of complaint. • No “pro-active” components included. • General company PMS procedures with no clear references or linkages to the device. • PMS only referenced in Risk Management Report with references to periodic updates. • Failure to implement previously described PMS plan (often identified on review of changes / renewals) • In audits when reviewing class I or IVD self certification in many cases there is NO PMS plan on paper

The Organisation for Professionals in Regulatory Affairs

22