Post-Market Surveillance Tool

What is Post-Market Surveillance?

Medical device Post-Market Surveillance (PMS) is defined as the activities that a manufacturer institutes and maintains, in order to proactively and systematically collect and review data on a device after it is placed on the market.

The purpose of collecting and reviewing the data is to identify any need to immediately apply either proactive or reactive actions depending on the data. PMS has been made a regulatory requirement under the EU Medical Device Regulation (EU MDR), which assert that manufacturers are required to have a PMS system as an aspect of their Quality Management System (QMS).

PMS enables manufacturers to adopt a lifecycle approach to their device management and allows them to continuously and proactively identify and initiate corrective or preventive actions.

What is Post-Market Surveillance?

Medical device Post-Market Surveillance (PMS) is defined as activities that a manufacturer institutes and maintains in order to proactively and systematically collect and review data regarding a device after it is placed on the market.

The purpose of collecting and reviewing the data is to identify any need to immediately apply either proactive or reactive actions dependent on the data. PMS have been defined and made a regulatory requirement under the EU Medical Device Regulation (EU MDR), which assert that manufacturers are required to have a PMS system as an aspect of their Quality Management System (QMS).

PMS enables manufacturers to adopt a lifecycle approach to their device management and allows them to continuously and proactively identify and initiate corrective or preventive actions.

What our tool offers

A CUSTOMIZED SAAS TOOL FOR THE MED-TECH INDUSTRY

13FOUR85’s PMS system tool has been specially designed and developed with the MedTech industry and the new EU MDR in mind.

Our team is constantly improving the tool’s features and effectiveness in cooperation with industry-leading consultants and companies.

 

 

OPTIMIZED WORKFLOW WITH 24/7 ROBOTIC SURVEILLANCE

The tool’s robot technology is set-up to automatically search the most relevant sources within the chosen therapeutic area 24-7, so you can focus on other important tasks.

Additional custom sources can be included upon request.

COMPLY WITH EU MDR REQUIREMENTS

The EU MDR requires documentation of systematic gathering, analysis, and recording of relevant data.

Our PMS system tool will help ensure your compliance through surveillance of relevant academic literature databases, various media outlets, publicly available competitor information, social media and other bodies.

OVERVIEW OF MARKET TRENDS & COMPETITOR ACTIVITY

Acquire the latest data from the social media sphere where a long list of key opinion leaders shares their thoughts on market trends etc.

Explore the opportunity of customizing the tool to pick up data on your competitors’ latest market activities.

 

 

A CUSTOMIZED SAAS TOOL FOR THE MEDTECH INDUSTRY

13FOUR85’s PMS system tool has been specially designed and developed with the MedTech industry and the new EU MDR in mind.

Our team is constantly improving the tool’s features and effectiveness in cooperation with industry-leading consultants and companies.

 

OPTIMIZED WORKFLOW WITH 24/7 ROBOTIC SURVEILLANCE

The tool’s robot technology is set-up to automatically search the most relevant sources within the chosen therapeutic area 24-7, so you can focus on other important tasks.

Additional custom sources can be included upon request.

 

COMPLY WITH EU MDR REQUIREMENTS

The EU MDR requires documentation of systematic gathering, analysis, and recording of relevant data.

Our PMS system tool will help ensure your compliance through surveillance of relevant academic literature databases, various media outlets, publicly available competitor information, social media and other bodies.

 

OVERVIEW OF MARKET TRENDS & COMPETITOR ACTIVITY

Acquire the latest data from the social media sphere where a long list of key opinion leaders shares their thoughts on market trends etc.

Explore the opportunity of customizing the tool to pick up data on your competitors’ latest market activities. 

 

 

 

What is PMS data?  

 

Types of proactive PMS data (Source: The European Forum of Notified Bodies Medical Devices)

 

 

  • Focus groups
  • Customer surveys
  • Post-market clinical trails
  • Literature reviews
  • User reactions during training programmes
  • Other bodies (e.g. Competent Authorities)
  • The media
  • Experiences with similar devices made by the same, or a different manufacturer
  • In-house testing

 

 

Types of PMS data

(Source: EMERGO)

 

 

  • Literature reviews
  • Post market clinical follow-up studies
  • Patient registries
  • Customer complaints
  • Customer surveys
  • Expert user group feedback
  • User reaction during training programs
  • Media content
  • Trade shows
  • Maintenance/ service reports
  • Field evaluation
  • Retrieval studies on explants or trade-ins
  • In-house testing
  • Failure analysis

Types of proactive PMS data (Source: The European Forum of Notified Bodies Medical Devices)

 

  • Focus groups
  • Customer surveys
  • Post-market clinical trails
  • Literature reviews
  • User reactions during training programmes
  • Other bodies (e.g. Competent Authorities)
  • The media
  • Experiences with similar devices made by the same, or a different manufacturer
  • In-house testing

 

 

Types of PMS data

(Source: EMERGO)

 

  • Literature reviews
  • Post market clinical follow-up studies
  • Patient registries
  • Customer complaints
  • Customer surveys
  • Expert user group feedback
  • User reaction during training programs
  • Media content
  • Trade shows
  • Maintenance/ service reports
  • Field evaluation
  • Retrieval studies on explants or trade-ins
  • In-house testing
  • Failure analysis

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 28 12 34 50

Contact

Contact 13FOUR85 to start your tailor-made guided journey today.

+45 28 12 34 50