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MedTech Regulatory Management (RIM)
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Featured Content

FDA Outlines its Approach to Artificial Intelligence Regulation

March 17, 2024

“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.

FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

March 12, 2024

The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and focuses on information FDA considers necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”

Registration Opens for March IMDRF Meeting in Washington, DC

February 7, 2024

The 25th session of the International Medical Device Regulators Forum will be held March 11-15 in Washington, DC. The free event is open to the public and includes both in-person and virtual attendance options, Registration deadline is February 16.

Key Barriers to RWD Adoption

February 7, 2024

A new survey from Frost & Sullivan highlights the key barriers to adoption of real world data and analytics in health care and life sciences.

European Commission Proposes Extension for EU IVDR Compliance

January 24, 2024

If adopted, companies would have additional time—from 2027 to 2029, depending on the type of device—to gain approval under EU IVDR.

See more News at the MedTech Regulatory Management (RIM) Resource Archive ››

Essenvia Platform – Product Demo

Crossing the eSTAR Chasm – Watch the Webinar

The Essenvia Platform explained in 2-minutes.

How to accelerate eSTAR submissions

MedTech Regulatory Submissions The Hard Way vs The Easy Way

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

Sponsored By Essenvia

This paper will educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources, and operations to seamlessly adopt the eSTAR as the new submission standard.

Read More

Crossing the eSTAR Chasm – The First MedTech Benchmark Report on FDA’s 510(k) eSTAR Mandate

Crossing the eSTAR Chasm – The First MedTech Benchmark Report on FDA’s 510(k) eSTAR Mandate

Sponsored By Essenvia

In this groundbreaking report, Essenvia shines a first-ever light on regulatory professionals' preparedness, benchmarks, and best practices for embracing eSTAR and overcoming the challenges MedTech companies face in adopting the new mandate.

Read More

Articles

  • What is Regulatory Excellence? And why it is critical for MedTech companies
  • The impact of modern Regulatory (RIM) technology on time to market
  • Why use a Regulatory (RIM) Platform to manage Product Registrations?
  • How can RA teams take advantage of Regulatory Intelligence?
  • Modern Regulatory (RIM) Platforms and Class III PMA

Regulatory Knowledge Base

  • Highlights of RAPS Convergence 2023: eSTAR takes center stage
  • Your guide to the FDA eSTAR program
  • Your Guide to European CE Mark for Medical Devices

Featured Articles

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.

May 20, 2026

The Boston Children’s Experience: Hidden ICU Risk and AI-Driven De-escalation

By Evan Butler

Boston Children’s Hospital physicians say one of the greatest risks in pediatric ICUs is delayed de-escalation of care, which can expose children to prolonged ventilation, sedation, and vasoactive medications. They argue that AI-driven clinical intelligence can help clinicians identify safer timing for weaning and extubation, supporting recovery and improving long-term outcomes.

May 18, 2026

Medtronic Bets on Cardiovascular Realignment Amid Stock Pressure and Facility Closures

By MedTech Intelligence Staff

Medtronic is overhauling its cardiovascular business in a major restructuring that includes new operating divisions, ongoing acquisitions, and a strategic push into higher-growth cardiac technologies. At the same time, the company plans to close its longtime Santa Rosa facility, affecting hundreds of employees and marking a significant shift in its U.S. manufacturing footprint. The changes come as Medtronic navigates investor pressure, intensifying competition, and a rapidly evolving cardiovascular device market.

May 11, 2026
Field Service Technology

The Hidden Design Flaw in Medical Device Service Technology

By Ryan Condon

Health systems globally face higher utilization, tighter scrutiny, and less operational slack. As devices become more connected and service events more consequential, the limitations of generic service technology become harder to ignore.

View More Combination Products Articles »

TOPICS

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

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