Post Market Surveillance | Vigilance | Post Market Clinical Follow-up
Three extremely important quality/regulatory processes which share some characteristics but they are by no means the same thing. An easy major non-conformance will come from handing your notified body assessor your Post Market Surveillance reports and saying that it covers the post market clinical follow up requirement. Another major issue occurs if they are not updated on a regular basis and clearly linked to your CAPA, design and risk management processes.
Horizon Phoenix experts have established PMS, Vigilance PMCF and clinical evaluations for everything from oxygen tubing to electromedical equipment to in vitro diagnostics. Our experts are available to perform this critical service for you or to work on-site teaching your team how these processes work and what to do with the valuable results.
What will you gain from robust post market information gathering and insightful evaluation:
- Build trust between you and your notified body and with those you regulate you.
- Devices and services that truly do continuously improve.
- Unshakeable customer loyalty.
- Improved performance for less cost.
- Tremendous advantage when accessing new or expanded markets.