Post-Market Surveillance & Compliance
Even the very best clinical testing cannot anticipate every potential outcome of using a medical device. That’s why, once a device has been approved and is out in the real world, it’s crucial to continue monitoring its use in order to protect patients.
In the post-market surveillance stage, we help our clients to collect multilingual data and translate it quickly and accurately for regulatory and monitoring purposes.
Specific Ways We Can Help.
Logistics & distribution
- We translate guidance to ensure your supply chain adheres to Good Distribution Practice, and help you stay on top of local and international regulatory changes.
Post-market surveillance (PMS) reports
- We translate these crucial reports within the timeframes dictated by regulatory bodies, and ensure you are capturing issues, analysis, and actions across all relevant languages.
Vigilance reports & adverse event reports (AERs)
- The timelines for interpreting and acting on adverse event reports can be extremely tight. We leverage AI to speed up and simplify translation of large volumes, to help you stay compliant and prevent issues from reoccurring.
Complaint handling reports
- We translate complaint handling reports for all markets and bodies, so our clients can ensure patient safety and satisfy regulatory requirements around the world.
Device labeling updates
- We translate updates prompted by new safety information or changes to regulation. We can isolate updated content only for streamlined translation, and offer DTP services across all languages.
Post-market clinical follow-up studies (PMCFs)
- We can help you communicate with markets to proactively gather information, and can ensure these living documents remain consistently up to date across languages.
Overcoming the Challenges of Post-Market Surveillance.
The most obvious challenge of the post-market surveillance stage is time. Once our clients’ products are in multiple markets, there is a wealth of data generated about their use and effects. It’s essential to access and interpret this data quickly, filter through noise, and take action where appropriate. We help our clients keep pace with use of their devices in multilingual markets, using custom-built AI to translate swiftly at scale before zooming in.
The costs of this stage can also be significant, with large volumes of data to translate and significant resources required to manage the process. Our clients centralize their multilingual information with Conversis for rapid AI-assisted translation and careful management.
Post-market surveillance can be a challenging stage from a regulatory perspective – staying across what needs to be reported, how, when, and to whom. Our regulatory team keeps up to date with international regulatory shifts, while our linguists are embedded in their local regulatory landscapes.
Why Work With Us.
Trusted by organizations all over the world
Case Studies.
FAQs.
Costs and timelines for translation can vary depending on factors like languages, volumes, and content type. We provide a quote for each new project, which includes costs and delivery timelines. Please get in touch if you would like us to produce a quote for you.
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