Katja, tekijä sivustolla Nometech Oy - Medical Device Regulatory & Quality Services

Illustration showing how regulatory debt in medical device development accumulates beneath compliance processes

Regulatory Debt. What it is and Why It Always Comes Due at the Worst Possible Moment?

CE, EU MDR, FDA, QMS, Regulatory, Uncategorized

Regulatory debt in medical device development I think you have heard the word “Technical debt”. It is “a qualitative description of the cost to maintain a system that is attributable to choosing an expedient solution for its development.” The term technical debt was coined by Ward Cunningham in 1992 but after that it has been revised, with the main highlight being

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A notebook with handwritten notes about FDA QMSR effectiveness verification

FDA QMSR is effective now!

FDA, QMS, QMSR

FDA QMSR is in effect. What comes after implementation? On January 31st, 2024, FDA released their final rule amending the Quality System Regulation (QSR) to better align with ISO 13485:2016, the international standard for quality management systems for medical devices. The final rule changes the title of 21 CFR Part 820 from the Quality System Regulation to the Quality

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MedTech regulatory documentation with post-it notes showing questions about EU MDR, FDA, device classification, QMS and regulatory timelines.

The Three Strategic Headaches of a MedTech Startup Founder and How to Solve Them Early

CE, EU MDR, FDA, IVDR, QMS, Uncategorized

Medtech startup regulatory strategy often determines the outcome of the race between innovation and regulation. For a founder, the reality is like trying to run fast while assembling the track underneath you. The pressure isn’t just about building a great product. It’s about making decisions early that quietly determine whether the company can ever sell

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Updated FDA guidance: Clinical Decision Support Software

FDA

On January 2026 FDA updated Clinical Decision Support guidance. Updated guidance: Clinical Decision Support Software. This updated guidance supersedes “Clinical Decision Support Software” issued on September 28, 2022 guidance document. Definitions To make the guidance easier to follow, here are a few key terms used throughout this article: CDS (Clinical Decision Support)Software intended to support

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Interesting news for wellness companies

FDA

FDA just released new policy related to Low-Risk devices: General Wellness: Policy for Low Risk Devices | FDA First of all what is Low risk general wellness device? The FDA defines general wellness products as products that meet two criteria:1. they are intended only for general wellness use, and2. they present a low risk to

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Vibrant American flag waving against a striking cloudy sky, symbolizing freedom and patriotism.

FDA QMSR 2026: Key Changes for Medical Devices

FDA

Let’s take a closer look at one of the most impactful FDA-related changes coming at the start of 2026 and what it actually means in practice. In the U.S., FDA’s new QMSR comes into force on 2 February 2026. While it aligns Part 820 with ISO 13485, ISO certification alone won’t automatically meet all FDA

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European Union flag with missing stars representing Brexit concept.

Medical Device Regulation in 2026: What to Expect

CE, EU MDR, FDA, IVDR

As 2025 comes to a close, many quality teams are already starting to look ahead to what 2026 will bring and how best to prepare for it. Let’s take a closer look at the most significant changes to prepare for early in the year. U.S FDA QMSR will come force on 2 February 2026. Harmonization

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