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Sponsored by Celegence

Post-Market Surveillance

Featured Content

February 3, 2026 | By Pujitha Gourabathini

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

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

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

April 10, 2026

The Healthcare Burnout Backlash (pt 3): How Workflow Redesign Is Helping Healthcare Organizations Offset Staffing Shortages

By Melissa Corneal

As organizations introduce additional technologies, including AI-enabled tools and CRM platforms, these gaps become more pronounced. Those that are seeing meaningful improvements are taking an end-to-end view, evaluating how systems interact within a unified workflow and ensuring that data flows seamlessly and actions are triggered in a coordinated manner, thereby reducing the need for manual intervention and follow-up.

April 3, 2026

The Healthcare Burnout Backlash (pt 2): Positioning AI pilots for success within EHR-integrated environments

By Melissa Corneal

In this part 2 of a 4-part series, Melissa highlight how the moment AI begins to influence decisions or workflows, it is operating within a regulated environment. Aligning with documentation standards, keeping data within established pathways, and ensuring actions are consistently recorded are all ways to support that reality early, rather than adapting to it later. Seen this way, integration is not just a technical milestone.

April 1, 2026

How Rural Health Systems Are Advancing Cardiac Imaging

By Dr. Joseph Cardenas, Dr. Khidir Osman MD, FACC

Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are increasingly looking to cardiac CT to redefine how advanced imaging can be delivered closer to where patients live.

April 1, 2026
north star

Beyond Reimbursement: Why Market Access is MedTech’s Strategic North Star

By Joan Hinrichs

Companies that embed Market Access early in innovation are the ones best positioned to navigate the changing global landscape.

April 1, 2026

The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms

By Shreya Sridhar

Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.

March 28, 2026
Healthcare Burnout

The Healthcare Burnout Backlash (pt 1): Burnout Reaches Well Beyond Clinicians

By Melissa Corneal

In this part 1 of a 4-part series, we look at how the burden of digital transformation is impacting the entire healthcare ecosystem, and that while burnout in healthcare is most often framed around clinicians, it does not reflect where the full transformation work is actually being carried...or its impact across healthcare.

March 25, 2026
healthcare data

Clinical Trials Have Too Much Data…That’s the Problem.

By Melissa Mooney

Data has become overwhelming in healthcare. While it has provided tremendous solutions and outcomes, however, it can sometimes be a problem, too! How can data utilization in Clinical Studies and a ground up data strategy help make your technologies, your team, and your trials more efficient?

March 16, 2026
QMS Interoperability

Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First?

By Carl Washburn

To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.

View More Combination Products Articles »

TOPICS

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

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