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MTI Resources

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Sponsored by Celegence

Post-Market Surveillance

Featured Content

July 7, 2026 | By Aalap Patel, MS, CQE, CSSBB

From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance

April 20, 2026 | By Jonathan Messer

Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices

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

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

July 7, 2026
AI in the EHR

Applying Agentic AI to Healthcare Delivery: The Key to True Transformation

By Jaimon Jose

MTI Viewpoints Insights shared by industry relative to healthcare and...

July 7, 2026
post market surveillance

From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance

By Aalap Patel, MS, CQE, CSSBB

Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports. However, many organizations still struggle to translate these insights into timely clinical action and meaningful patient safety improvements. This article examines the growing disconnect between regulatory reporting and operational decision-making, explores the challenges of signal detection and prioritization, and outlines practical strategies for building closed-loop PMS systems that improve patient safety outcomes and organizational responsiveness.

June 29, 2026
AI Compliance in Medical Devices

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Geethapriya (Priya) Setty

By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was already running behind.. How can your organization move forward? An Operational AI Capability Maturity Model — a five-domain framework built specifically for regulatory affairs and offers a direct way to assess where your organization actually stands. If your team cannot consistently answer who approved the tool, how the output was verified, and what was retained, this framework is a practical place to start.

June 1, 2026

MedTech In Focus: AI impact in healthcare

By MedTech Intelligence Staff

The most recent AI thought leadership published on MedTechIntelligence.com.

June 1, 2026

If Your AI Can’t Explain Itself, Can FDA Authorize It?

By Lavanya Ramnath, Srividya Narayanan

Why is algorithmic transparency becoming an increasingly important consideration in FDA's review of AI/ML medical devices?

May 20, 2026

Fixing Eligibility at the Point of Care: The Missing Link in Medical Device Reimbursement Integrity

By Peter Justen

MTI Viewpoints Insights shared by industry relative to healthcare and...

May 20, 2026

The failure of the ‘usual suspects’ approach to life science recruitment

By Ivor Campbell

How has AI impacted the way in which companies recruit for senior specialists, particularly in highly niche roles in MedTech, biotech and pharmaceutical development? Finding the right people for these roles has never been harder.

May 20, 2026
Justice scale, healthcare, cost

Value, Focus, and the Future of MedTech: M&A and Divestitures are Rewriting the Strategic Playbook.

By Joan Hinrichs

Market Access is now the central input into M&A and value-driven divestitures, enabling MedTech leaders to reshape portfolios for strategic advantage, long-term growth, and greater value to patients - unlocking their full potential.

View More Combination Products Articles »

TOPICS

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

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