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Quality/Regulatory

Dr. Christopher Joseph Devine, President, Devine Guidance International
February 9, 2010
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

1st Article Inspection and Supplier Statistical Data

By Dr. Christopher Joseph Devine

If you are a returning visitor, welcome back to this 4th installment of Devine Guidance. If this is your first time, I hope you have a chance to read the first-three installments of my blog.  In this installment, I will continue with the defensive-receiving inspection theme, a process that I feel “has limited-value.” That said,…

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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

November 17, 2025

Navigating U.S.-EU Medical Device Regulation: Innovative Strategies for Global Compliance

By Holger Wagner
Aligning MedTech Compliance

The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality Management System Regulation (QMSR) setting new benchmarks.

November 9, 2025

What is a Service+Tech Model?

By Lakshmeenarayana Goundalkar (LGG)
AI Compliance in Medical Devices

The Service+Tech model embeds AI into the workflow of regulatory experts rather than treating technology as a standalone tool; an approach allowing organizations to adopt AI immediately, with no risk and no R&D investment, while keeping full confidence in the accuracy and regulatory readiness of submissions.

September 30, 2025

4 FAQs to Notified Bodies

By Kevin Holochwost
medtech design standards

Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.

September 26, 2025

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

By MedTech Intelligence Staff, Rene Zoelfl
Product Lifecycle Management

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

September 11, 2025

Beyond Automation: How AI Transforms Clinical Evaluation Reports into Strategic Regulatory Assets

By Celegence
Clinical Evaluation Reports and Artificial Intelligence

Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, surveillance, and quality management to enable real-time adaptability. Artificial Intelligence (AI) , in particular, is playing an increasingly critical role in helping manufacturers meet expanding regulatory expectations.

August 17, 2025

Top MedTech Trends in 2025

By Rene Zoelfl

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry's ability to make technology a part of everyday life will be key to driving growth and evolving with the demands of a disparate patient population.

August 17, 2025

Streamlining Compliance for Quicker MedTech Market Entry

By Manuela Kohlhas
MedTech Compliance Process

As these regulations continue to change, MedTech companies need to leverage the right systems to streamline processes, ensure continuous compliance, and mitigate the risks associated with non-compliance

July 9, 2025

Japan Reimbursement (Part 2): How to increase Japan reimbursement after receiving initial Japanese pricing

By Ames Gross

Many medical device companies want to go to Japan since it is the third-largest market in the world. Oftentimes, device companies want to register their devices quickly in Japan to be on the market and are not focused enough on the initial medical device reimbursement they will get. This can lead to an unprofitable business if the Japanese reimbursement price is not higher than the sales price in Japan. Are there strategies to increase reimbursement?

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

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