Let Our Team Answer These Key FDA & EU PMS Questions
-
What are the current FDA and EU postmarket requirements?
-
Does our current process meet these PMS requirements?
-
Are we collecting enough PMS data and is it the right data?
-
How do ISO/TR 20416, ISO 13485 and ISO 14971 overlap?
PMS is More Important to FDA, EU and Other Regulators Than Ever Before
Over the years, regulatory authorities have started placing far more emphasis on the full life cycle of medical devices and IVD’s, well beyond regulatory approval. Ongoing safety and performance monitoring is now critical. FDA inspectors and European Notified Bodies expect you to have a proactive process in place to monitor, collect and evaluate customer complaints and adverse events. Many manufacturers don’t and this can lead to problematic FDA 483 or Notified Body audit findings.
Let’s Elevate Your PMS Process
Whether you sell one device or one thousand, Oriel STAT A MATRIX helps medical device and IVD manufacturers evaluate their existing postmarket surveillance process, looking at existing procedures and offering detailed recommendations for improvement. We can do the same for you, digging deep to review your:
-
Existing postmarket surveillance plan (or create one for you)
-
Linkages between your QMS and risk management processes
-
Current PMS monitoring procedures and practices
-
Complaint handling procedures
-
Data collection, analysis and investigation methods
-
Framework for Medical Device Reporting (MDR) and trend analysis
Based on our findings, we will prepare a detailed gap analysis including clear, actionable steps your team can take to bring you into full compliance with the regulations and avoid thorny PMS issues during your next audit.
Need Help with Ongoing PMS Maintenance?
Knowing what should be done and actually doing it are two entirely different things. Many companies without adequate internal resources ask us to help maintain specific part or all of their post market surveillance system. You choose what to handle internally and let us do the rest. With teams in the US, Europe and Asia, you are getting access to a deep team of medical device QA/RA professionals that is ready to assist with serious incidents and FSCA situations as needed. Find out more about how we help companies with PMS outsourcing.
We’re Ready to Help
Oriel STAT A MATRIX specializes in helping Medical Device and IVD companies comply with US and EU regulations. Learn how we can assist in bringing your PMS system into full compliance with the FDA QSR, EU MDR and all applicable international standards and regulations.