We support postmarket surveillance across your product’s workflow

PLG can help you implement postmarket surveillance (PMS).

The PMS system should be both reactive and proactive and should include descriptions of (1) the ways the PMS will be carried out and (2) the PMS plan for each product, as specified by the Medical Device Coordination Group in its guidance on clinical evidence.

Services we offer :

  • Implementation of your PMS system and PMS plan
  • Creation of the periodic safety update report (PSUR)
  • Determination of the processes needed for identification and implementation of corrective and preventive action (CAPA)
  • Management of complaints and application of our related-market experience
  • Monitoring of trends

Our expertise in handling postmarket surveillance plans

PLG supports you with:

  • Global and local literature searches
  • Trend reporting
  • PMS comparison with similar medical devices
  • Serious-incident handling and field safety corrective actions
  • Handling of nonserious incidents and undesirable side effects
  • Dealing with complaints and surveys


Focus on PSURs and postmarket clinical follow-up (PMCF)

  • Search conducted in PubMed using predefined search string
  • Review of applicable articles entered into a dedicated tool as evidence of literature evaluation activity management. ; justification for inclusion or exclusion provided
  • Annual report drafted per device, with results included in PSUR

How we manage literature searches, safety alerts, PMS reports, and PSURs:

  • Global literature: Systematic review of all sources throughout the year, conducted once a year
  • Literature search performed on a quarterly basis for better oversight of the profile of the safety device
  • Monitoring of authorities’ websites once a month