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Medical Devices

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

Post-market surveillance (PMS) reports

Vigilance reports & adverse event reports (AERs)

Complaint handling reports

Device labeling updates

Post-market clinical follow-up studies (PMCFs)

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.


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Sector experts for 20+ years
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3,000+ linguists
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110 countries
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ISO 9001, 17100 & 27001 certified
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330+ language combinations
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Track record in 50+ therapeutic areas
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Cover entire medical device lifecycle
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Custom AI for post-authorization needs

Trusted by organizations all over the world

Johnson and Johnson
Fresenius
IQVIA
Roche
AngioDynamics
syneos
Sanofi
Atos Medical
Langland
Bristol Myers
Eakin Surgical
Havas
Boston Scientific
 Alcon
Ogilvy Health
Abbvie
Helios Global Group
glaxosmithkline

FAQs.

What are the costs and turnaround times for translation?

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.

How do you ensure data privacy?
Conversis is fully compliant with GDPR and all applicable data privacy requirements, as well as being ISO 27001-certified for information security. Our compliance is continuously monitored and reviewed through data protection audits and regular policy updates, ensuring adherence to evolving legislation and standards.
I would like to work with Conversis. How do I get started?

We’re delighted to hear it! To get started, please complete our contact form and the appropriate team will be in touch to arrange an initial conversation.

Let’s talk.

We look forward to hearing from you.
We look forward to hearing from you.