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Post-Market Surveillance

Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches.

With deep expertise in post-market surveillance requirements, Emergo is equipped to act as your compliance partner long after your device goes on the market. We can help you design and implement a PMS system that meets requirements in multiple markets and navigate regulatory challenges throughout the device lifecycle.

Global vigilance support for medical device and IVD companies

Emergo represents more than 2,000 medical device and IVD companies as an official in-country representative, so we are constantly helping companies with vigilance reporting in markets worldwide, including:

We can help determine when incidents are reportable and ensure vigilance reports are completed on time and in compliance with local requirements.

Multi-disciplinary post-market risk management and support

Our experts have in-depth product knowledge covering a wide range of functional and technical disciplines that support medical device post-market risk management activities. From designing and executing a post-market clinical follow-up (PMCF) study to conducting a root cause analysis of your device in response to an adverse event, we collaborate with you to deliver a proprietary solution to your post-market needs.

Questions? Request more information from our specialists

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MDR Workshop, Mar 25, 2019 to Apr 4, 2019 in Boston, MA or Fremont, USA

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Post-Market Surveillance

Australia | Post-Market Surveillance

Medical Device Vigilance Reporting in Australia

Mexico | Post-Market Surveillance

Medical Device Vigilance Reporting in Mexico

Singapore | Post-Market Surveillance

Singapore Vigilance Reporting for Medical Devices

South Korea | Post-Market Surveillance

South Korea Medical Device Vigilance Reporting

Taiwan | Post-Market Surveillance

Medical Device Vigilance Reporting in Taiwan

United States | Post-Market Surveillance

FDA eMDR Adverse Event Reporting for Medical Device Companies