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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FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations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The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” and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

September 21, 2026
Product Development, Human factors engineering

Reverse Engineering in Medical Device Design: When and Why It Makes Sense

By Khushali Solanki

Reverse engineering carries a reputation problem in medical device circles; it sounds like copying. In practice, it's a legitimate engineering discipline with specific, defensible use cases: replacing obsolete components, improving an existing design's manufacturability, and indigenizing imported parts. This article looks at when reverse engineering genuinely makes sense in medical device development, the technical process involved, and the intellectual property considerations teams need to navigate before using it.

August 20, 2026

AI-Assisted Triage: Accelerating Post-Market Surveillance While Eliminating Reporting Blind Spots

By Binitkumar M. Vaghani

Complaint volumes have outgrown manual triage, and medical device companies are turning to AI to keep up. The speed gains are real, but used carelessly the same tools can bury a reportable event at the bottom of a queue while the MDR clock runs. This piece maps where AI genuinely helps in post-market surveillance, where human judgment has to stay, and what validation, monitoring, and audit trails a defensible program needs. It is grounded in the current regulatory frame, including the QMSR and FDA's new inspection program (CP 7382.850) that took effect February 2, 2026, 21 CFR Part 803 reporting timelines, and ISO 13485 software validation expectations. It includes a practical table drawing the line between tasks that are safe to automate and decisions that must stay human-owned. The intended audience is quality, regulatory, and post-market surveillance professionals in the medical device industry.

August 19, 2026

Sensors at the Edge: Powering Smarter Healthcare

By Daraius Patell

As healthcare shifts towards remote monitoring, connected devices and decentralized care, sensor technologies are becoming increasingly foundational to how medical devices collect, validate and transmit critical information. From remote patient monitoring and at-home care to connected medical devices and robotic-assisted surgery, sensing technologies can help enable earlier detection, more reliable clinical data and better-informed decision making.

August 19, 2026

Devices are Getting Smarter, Making Materiovigilance Evolve Faster

By Dr. Padmalakshmi Jnaneshwar

According to Deloitte, only 22% of life sciences leaders say they have successfully scaled AI, and just 9% report achieving significant returns. For materiovigilance, this highlights the growing gap between execution and team expectations. Within this gap, fragmented data and manual processes continue to slow response times and increase compliance risk, creating a disconnect between the promise of real-time safety monitoring and operational reality. How can organizations close this execution gap and evolve materiovigilance from a reactive compliance function into a proactive, data-driven discipline?

August 18, 2026

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.  

August 10, 2026
Balancing Cyber Risk

What 524B and QMSR Change About Medical Device Risk

By Kaleb Averell

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, recall, and management liability. Where device makers are commonly unprepared against the new baseline, including the gap between cyber risk and product liability for software and devices.

August 10, 2026

Taking Lean Manufacturing to the Next Level

By Matt Stekier

The increased digitalization of medical device manufacturing makes lean practices more applicable than ever. Keep these factors in mind to put them into action.

August 10, 2026

Why Few MedTech Sales Teams Are Using AI Where It Matters Most

By Lee Smith

A MedTech survey revealed that most sales teams are not using AI for strategic purposes, such as identifying opportunities, prioritizing accounts, or research. Instead, AI is mostly deployed to complete administrative tasks, such as drafting emails and summarizing meetings. Why is more needed?

View More Combination Products Articles »

TOPICS

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

Upcoming Events & Webinars

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