We Can Address These Common PMS Questions
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Are our current PMS procedures adequate?
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How can we optimize our PMS monitoring methods?
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To what extent do we need to proactively gather PMS data?
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Can we outsource some or all post market surveillance?
Outsource Some or All of Your PMS Process
Medical device manufacturers often come to us in two situations:
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An FDA inspection or Notified Body audit revealed that their PMS process is inadequate
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A viable PMS program is in place, but they lack the internal staff to properly maintain it
Whatever your situation, we have a deep team of RA/QA professionals that understand how to optimize and maintain a functioning post market surveillance system in compliance with FDA, EU MDR, MDSAP and more. Areas in which we can assist:
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PMS plan evaluation or creation of a new plan
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Proactive review of complaints in public databases including MAUDE, MedSun, EUDAMED and SARA (Australia)
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Reactive evaluation of complaints from users, distributors and importers
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Preparation of EU Manufacturer Incident Reports (MIR) and FDA reports
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Data collection and analysis
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PMS event reporting and EUDAMED upload
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Field Safety Notices (FSN) and Field Safety Corrective Actions (FSCA)
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PMCF, PMSR, PSUR, or SSCP preparation
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Trending and statistical analysis
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Clinical data collection
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Literature searches
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Reassessment of benefit-risk analysis
US, EU, Australia, Brazil, Canada, China, Japan and more
Many of our clients sell in a variety of markets. Our team has experience in all of these markets and more so we can help optimize your PMS procedures to meet the specific collection and reporting requirements of different regulatory authorities. We have expertise with specific global PMS and risk management requirements contained in:
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US FDA 21 CFR Part 820 |
ISO 14971:2019 |
ISO/TR 20416:2020 |
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ISO 13485:2016 Clause 8 |
EU MEDDEV 2.12/1 |
And many more! |
We’re Ready to Help
Oriel STAT A MATRIX specializes in helping medical device and IVD companies comply with international regulations. Learn how we can assist in maintaining your post market program in compliance with FDA, EU and international requirements.