NEW! MedTechMonitoring: Ongoing Post-Market Surveillance

Home
Our Services
  • Regulatory Services
  • Project Management
  • Clinical Study Writing
  • Training and Education
  • Templates and SOPs
MedTechMonitor
WORK WITH US
About Us
Learn
  • Regulatory Requirements
  • Clinical Evaluations
  • PMCF
  • PMS

MedTech Writing and Consulting

MedTech Writing and ConsultingMedTech Writing and ConsultingMedTech Writing and Consulting
Home
Our Services
  • Regulatory Services
  • Project Management
  • Clinical Study Writing
  • Training and Education
  • Templates and SOPs
MedTechMonitor
WORK WITH US
About Us
Learn
  • Regulatory Requirements
  • Clinical Evaluations
  • PMCF
  • PMS
More
  • Home
  • Our Services
    • Regulatory Services
    • Project Management
    • Clinical Study Writing
    • Training and Education
    • Templates and SOPs
  • MedTechMonitor
  • WORK WITH US
  • About Us
  • Learn
    • Regulatory Requirements
    • Clinical Evaluations
    • PMCF
    • PMS
  • Sign In
  • Create Account

  • My Account
  • Signed in as:

  • filler@godaddy.com


  • My Account
  • Sign out

MedTech Writing and Consulting

MedTech Writing and ConsultingMedTech Writing and ConsultingMedTech Writing and Consulting

Signed in as:

filler@godaddy.com

  • Home
  • Our Services
    • Regulatory Services
    • Project Management
    • Clinical Study Writing
    • Training and Education
    • Templates and SOPs
  • MedTechMonitor
  • WORK WITH US
  • About Us
  • Learn
    • Regulatory Requirements
    • Clinical Evaluations
    • PMCF
    • PMS

Account


  • My Account
  • Sign out


  • Sign In
  • My Account

Clinical Evaluation

Medical device and MedTech manufacturers are required to perform a clinical evaluation to earn their initial CE marking, and to maintain these documents as per the MDR. The EU MDR defines clinical evaluation as "a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

Clinical Evaluation Plan (CEP)

These documents will include the literature search and other evaluation criteria which will be used to perform the clinical evaluation, the results of which are documented in the CER.

Clinical Evaluation Report (CER)

The CER documents the results of the CEP, with a large focus on reviewing literature and clinical investigations. Post market data is also reviewed as part of this report.

Learn more about clinical evaluations

Post-Market Clinical Follow Up

Post-market clinical follow-up is a type of post-market surveillance that utilizes a proactive approach. The clinical evaluation will determine whether a PMCF is required; not every medical device requires one. The EU MDR defines PMCF to be "understood to be a continuous process that updates the clinical evaluation."

Post-Market Clinical Follow Up (PMCF) Plan

PMCF Plans outline the intended strategy for collecting clinical data on a medical device that is - or once it is - on the market. It includes details such as the objectives, methods, study design, data analysis, timelines, responsibilities, and resources required for conducting PMCF activities, which can be general or specific.

Post-Market Clinical Follow Up (PMCF) Report

The PMCF Report summarizes the results of the planned activities part of the PMCF Plan and evaluates the device's/technology's continued safety and performance in real-world clinical use. This report is updated, at a minimum, on a predetermined cadence, and deviations from the PMCF Plan are noted.

Learn more about Post-market clinical follow up

POST-MARKET SURVEILLANCE

Post-market surveillance is a systematic process to collect and review data on the safety and performance of a medical device on the market. This information gathered, per the EU MDR, is used to review several items, including the benefit/risk profile, manufacturing information, IFUs, clinical evaluation, summary of safety and performance, technical documentation, corrective or preventive actions, and more.

Post-Market Surveillance (PMS) Plan

The PMS Plan outlines the strategy for systematically collecting and monitoring data on the safety and performance of a medical device on the market. At times, the PMS Plan can include a PMCF Plan, though the PMCF Plan is often a standalone document referenced as part of the PMS system.

MedTechMonitor: Ongoing Post-Market Monitoring

Interested in boosting your organization's awareness of public information about your device? We create a monthly report of publicly available data for your device using various sources, including adverse event reporting databases (FDA MAUDE, TPLC, Health Canada Reporting, SwissMedic, MHRA Reporting, etc.), literature (Embase. PubMed), and recalls (ECRI). 

We customize our strategy for your device, the level of desired reporting, and the regions where it is sold.

Post-Market Surveillance Report, Periodic Safety Update Report (PMSR, PSUR)

PMSRs and PSURs, required by the EU MDR, are largely written in the same manner, with a focus on the conclusions of the benefit-risk determination, the main findings of the PMCF, the volume of sales, and an estimated evaluation of the size and other characteristics of the population using the device. Class I devices require a PMSR, while all other risk classes require a PSUR.

Learn more about Post-market surveillance

MDR STRATEGY CONSULTATIONS

General Consulting Call

Ask our CE and PMS experts about CE and PMS compliance and requirements for your technology. 

TELL US MORE ABOUT YOUR REGULATORY NEEDS...

and we'll help you meet them!

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Our writers and consultants have worked with...

Medtronic

Edwards Lifesciences

Abbott Laboratories

Abbott Laboratories

Edwards Lifesciences

Abbott Laboratories

Edwards Lifesciences

Edwards Lifesciences

Edwards Lifesciences

Terumo

Baxter International

Edwards Lifesciences

Baxter International

Baxter International

Baxter International

HCL Technologies

Baxter International

Baxter International

...and more major organizations!

...and more major organizations!

...and more major organizations!

  • Home
  • Regulatory Services
  • Project Management
  • Clinical Study Writing
  • Training and Education
  • Templates and SOPs
  • WORK WITH US
  • About Us

MedTech Writing and Consulting

Copyright © 2024 MedTech Writing and Consulting - All Rights Reserved.

This website uses cookies.

We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.

Accept

Take a load off...

..and let us handle your ongoing Post-Market Surveillance. See how your device (and similar devices) are operating out in the market!

Learn more about MedTechMonitor