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MTI Resources

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Sponsored by Celegence

Post-Market Surveillance

Featured Content

June 6, 2024 | By Amelia Hufford, PhD, Phillip Stoltzfus

Reliable Active Surveillance: RWE for MedTech

May 24, 2024 | By MTI Marketing Staff

Ask the Expert: PMCF implementation under EU MDR

March 17, 2024 | By MedTech Intelligence Staff

FDA Outlines its Approach to Artificial Intelligence Regulation

March 6, 2024 | By Celegence

Enhancing Post-Market Surveillance: Strengthening Medical Device Regulation in the UK

January 30, 2024 | By Anushree Singh

Role of Clinical Evaluation Report Consultants

November 15, 2023 | By MedTech Intelligence Staff

FDA Recognizes AAMI SW96 Cybersecurity Guidance Document

August 30, 2023 | By MedTech Intelligence Staff

UK Releases Draft Post Market Surveillance Requirements for Medical Devices

Related Blogs

Europe PMC Integration in CAPTIS™
AI-Powered Solutions for Regulatory Compliance in the Medical Device Industry

PMCF under EU MDR
Strategies for Successful Post-Market Clinical Follow-Up (PMCF) under EU MDR: Insights from a Comprehensive Webinar

Guidelines for Systematic Reviews
Helpful Guidelines for Producing Your Systematic Reviews

Europe PMC Integration in CAPTIS™
Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership – Acumed

PMCF Insights
Insights into PMCF Requirements under EU MDR

Post-Market Clinical Follow-up
The Importance of Post-Market Clinical Follow-up for Medical Devices: Compliance and Beyond

Celegence Regulatory Soultions

Case Studies

PMS Report & PMCF Surveys

PMS Support & PMCF Surveys for a global Device Manufacturer


Project Summary: Long-term partnership between Celegence and a leading manufacturer of esthetic surgery devices for support with PMS and Clinical Evaluation documentation for complying with regulatory requirements of multiple countries/regions across the globe.

Clinical Evaluation & Support for an Emergency Use Medical Device


Project Summary: Manufacturers of a Class IIb emergency-use medical device required support in addressing observations from their Notified Body. The scope of work included advisory consulting for EU MDR compliance and medical writing support for Quality and Regulatory documentation.

Technology for EU MDR / IVDR Compliance

Europe PMC Integration in CAPTIS™
Europe PMC Integration in CAPTIS™

Time Saving in Literature Reviews with CAPTIS
Time Saving in Literature Reviews with CAPTIS

Data Extraction Tables in CAPTIS™
Data Extraction Tables in CAPTIS™

On-Demand Learning

PMCF under EU MDR

CER & PMS Document Writing

 

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Leveraging Technology to Optimize MDR Compliance Outsourcing & Partnership

Sponsored By Celegence

Download this case study for insights on optimized regulatory processes via tech-enabled services from Celegence. Acumed made their MDR compliance a success by boosting efficiency, saving time, and streamlining collaboration.

Read More

Medical Device Services

  • Post-Market Clinical Follow-up Guidance 
  • EU MDR Gap Analysis
  • UDI Consulting
  • CER / CEP Writing
  • Post-Market Surveillance
  • Medical Device Consulting
  • IVDR Consulting
  • EU Authorized Representatives Services

Regulatory Updates

FDA Updates Recognized Consensus Standards Database with List 61
FDA Issues a Final Rule Amending the Quality System Regulation (QSR)
FDA Scheduled Updates for the CDRH Customer Collaboration Portal Including New Features
An Inside Look: Formal Meetings Between PDUFA Product Sponsors or Applicants and the FDA

Featured Articles

November 27, 2024
sustainable design

From design to disposal: Reducing the footprint of single-use drug delivery devices

By Alex Fong

How can drug delivery devices manage competing priorities - reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.

July 8, 2024
LDT Development

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman

Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.

January 22, 2023
Rama Chellappa

Instilling Trust in AI

Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of "Can We Trust AI?" looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.

October 12, 2020
Arlen Ward, System Insight Engineering

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza

No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

September 2, 2020
Checkbox

Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer

By MedTech Intelligence Staff

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

June 15, 2020
Abbott FreeStyle Libre 2

FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children

By MedTech Intelligence Staff

The FreeStyle Libre 2 now has indications for children ages four and older.

May 25, 2020
FDA

In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

March 17, 2020
N95 respiratory mask

Amidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment Emerge

By MedTech Intelligence Staff

As the saying goes, if it looks too good to be true, it probably is.

View More Combination Products Articles »

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Upcoming Events & Webinars

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On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

Combination Products

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