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Quality/Regulatory

Dr. Christopher Joseph Devine, President, Devine Guidance International
February 1, 2010
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Specification Creation and Receiving Inspections

By Dr. Christopher Joseph Devine

To those who have decided to return for another episode of Devine Guidance , thank you! Once again, I hope you find some reading enjoyment and value in this third installment. For this adventure, I plan to dive into the importance of a clear and concise specification to support the design, development, and procurement processes.

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Columns

June 29, 2026

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Geethapriya (Priya) Setty
AI Compliance in Medical Devices

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?

April 30, 2026

From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market

By Lavanya Ramnath, Srividya Narayanan
Toddler Wearable Health Devices and Monitors

Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.

March 16, 2026

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

By Carl Washburn
QMS Interoperability

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.

February 23, 2026

Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care

By MedTech Intelligence Staff

Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.

February 3, 2026

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

By Pujitha Gourabathini
Safety of AI in Medical Devices

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

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock
Off-label and contraindicated medical device use

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

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

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