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FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations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The new draft guidance proposes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”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

February 3, 2026
Mental Health Reimbursement

Demand for Non-Pharmacological Mental Health Needs a Delivery System

By Allan Gobbs

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to accelerate scale.

February 3, 2026
Safety of AI in Medical Devices

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

By Pujitha Gourabathini

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.

January 20, 2026
Off-label and contraindicated medical device use

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

January 20, 2026
Balancing Cyber Risk

The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready?

By Justin Kozak

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?

January 20, 2026
ChatGPT

How ChatGPT Health is rewriting patient engagement

By Christoph Lippuner

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait to see a clinician. Despite this growing reliance on digital tools, the same survey revealed a disconnect in patient confidence, with almost 80% reporting that they do not feel fully in control of their healthcare. How might ChatGPT Health accelerate this shift, as well as what needs to happen to ensure AI adoption genuinely empowers patients rather than adding further complexity?

January 15, 2026
Domico Med-Device in Mexico

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

By Randy Knotts

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

January 6, 2026
Medical Device R&D Bottleneck

R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do?

By Venkatesan (Venkat) Muthukrishnan

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.

January 6, 2026
Superemployees - AI human evolution

How is AI Enabling Darwinian growth for Life Science Professionals?

By Ivor Campbell

The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.

View More Combination Products Articles »

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

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