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Post-Market Surveillance & Post-Market Clinical Follow-Up

We are committed to supporting our clients in all aspects of Post-Market Surveillance (PMS), ensuring the preparation and maintenance of comprehensive PMS documentation is seamless and stress-free.

Reducing costs
Cost-efficient

Due to a highly streamlined preparation process and high report volume in PMS reports and  PSURs, we can provide report creation services at very competitive price.

Radar
Automated

Explore "Spectrum", our medical device regulatory app platform to manage your device portfolio and prepare and maintain complex PMS documentation with a single click.

Broom
Clean

Retrieve appealing, well-formatted, clean output documents that are free of barriers and contain active links to identified literature and event reports for seamless document navigation.

Image by Kyle Glenn

PMS plan

Manufacturers are required to establish a comprehensive PMS plan that outlines how they will systematically collect and analyze data related to device performance, adverse events, and other relevant information. The plan should cover how the manufacturer will proactively monitor the device's safety and performance throughout its lifecycle.

PMS report

Turn data into actionable insights with our PMS Report Service. We'll compile and analyze your PMS data, generating comprehensive reports that allow you to proactively monitor and improve device safety and performance.

Arbeiten mit Finanzdokumenten
Finanzbericht

PSUR

Simplify your compliance process with our PSUR Service. We'll compile and summarize all adverse events and performance metrics, delivering a robust and compliant Periodic Safety Update Report (PSUR) for your medical devices.

Iteration

Regular PMS service

Stay ahead in regulatory compliance with our Post-Market Regular Update Plan. This all-inclusive service handles the creation and maintenance of all essential PMS documents, including PMS plans, PMCF evaluation plans / reports, PMS reports, and PSURs. Focus on your core competencies while we ensure your ongoing compliance with industry standards.

PMS plan

PMCF evaluation plan / report

PMS report / PSUR

Frequently asked questions

  • Molecule classes
    We can support you with our expertise across the full spectrum of drug development: from small to large molecules, biologics to oligonucleotides and more.
  • Development stages
    TODO
  • Species selection
    TODO
  • Technologies
    e.g. silencing novel approaches?

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