# iec (audio feeds) — RSS Amplifier

Recent posts from the 2 feeds in the RSS Amplifier directory that cover iec.

Page: <https://rssamplifier.com/topics/iec/audio>  
Feed: <https://rssamplifier.com/topics/iec/audio.md>

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## [Building a Strong Quality Management System: From Documentation to Real Compliance](https://podcast.easymedicaldevice.com/402-2/)

_2026-08-12 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

Having an ISO 13485 Quality Management System in place does not automatically mean that your quality processes are effective. A strong QMS should help an organization identify problems, evaluate their \[…\] The post Building a Strong Quality Management System: From Documentation to Real Compliance appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://ia600606.us.archive.org/17/items/episode-402_202608/Episode%20402.mp3)

## [Quality & Compliance: Building Stronger Medical Device Quality Systems](https://podcast.easymedicaldevice.com/401-2/)

_2026-08-06 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

Quality and regulatory compliance are fundamental to bringing safe and effective medical devices to market. As regulations continue to evolve and technologies become more complex, manufacturers must adopt a proactive \[…\] The post Quality & Compliance: Building Stronger Medical Device Quality Systems appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://ia600403.us.archive.org/16/items/episiode-401/Episiode%20401.mp3)

## [ISO/IEC 4213 2nd edition reaches Draft International Standard stage](https://adamleonsmith.substack.com/p/isoiec-4213-2nd-edition-reaches-draft)

_2026-08-03 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

From a technical specification to the standard nobody can avoid

## [prEN 18229-3 reaches Enquiry](https://adamleonsmith.substack.com/p/pren-18229-3-reaches-enquiry)

_2026-07-30 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

The standard that admits human oversight sometimes cannot work

## [Your Risk Management File Is Probably Fiction](https://podcast.easymedicaldevice.com/400-2/)

_2026-07-30 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

What would happen if your Risk Management File disappeared tomorrow? Would your medical device suddenly become less safe? For many organizations, the answer is probably no—because the file was created \[…\] The post Your Risk Management File Is Probably Fiction appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://ia601400.us.archive.org/5/items/episode-400/episode%20400.mp3)

## [Revised AI Act text available](https://adamleonsmith.substack.com/p/revised-ai-act-text-available)

_2026-07-24 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

My shortest article of all time.

## [The Audit Readiness Myth: Why Most Startups Aren’t As Prepared As They Think](https://podcast.easymedicaldevice.com/399-2/)

_2026-07-23 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

Many medical device startups assume they’re audit ready because they have documented procedures, completed templates, and a Quality Management System in place. However, successful audits require much more than organized \[…\] The post The Audit Readiness Myth: Why Most Startups Aren’t As Prepared As They Think appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://dn720006.ca.archive.org/0/items/episode-399_202607/Episode%20399.mp3)

## [EN 18286:2026 is finally published, the first AI Act standard to reach that milestone](https://adamleonsmith.substack.com/p/en-182862026-is-finally-published)

_2026-07-22 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

What changed since the public enquiry version?

## [The FDA Clearance Journey: What Nobody Tells Medical Device Startups](https://podcast.easymedicaldevice.com/398-2/)

_2026-07-16 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

For many medical device startups, obtaining FDA clearance seems like a clear, linear process. Identify a predicate device. Prepare your documentation. Submit your application. Wait for clearance. In reality, the \[…\] The post The FDA Clearance Journey: What Nobody Tells Medical Device Startups appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://ia600802.us.archive.org/30/items/episode-398_202607/Episode%20398.mp3)

## [The Audit Went Perfectly… So Why Are We Still in Trouble?](https://podcast.easymedicaldevice.com/397-2/)

_2026-07-09 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

For many medical device companies, a successful audit is seen as the ultimate proof that their Quality Management System is performing well. Few or no findings. Positive feedback from auditors. \[…\] The post The Audit Went Perfectly… So Why Are We Still in Trouble? appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://ia600102.us.archive.org/18/items/episode-397_202607/Episode%20397.mp3)

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_2026-07-08 · **Sponsored**_

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## [Medical Device News July 2026 Regulatory Update](https://podcast.easymedicaldevice.com/396-2/)

_2026-07-02 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

Stay up to date with the latest EU MDR, IVDR, UK MDR and Swiss Medical Device regulations. In this episode we cover: 🤝 Episode Sponsor Medboard 👉 MedBoard – The \[…\] The post Medical Device News July 2026 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://ia800601.us.archive.org/3/items/episode-396_202607/Episode%20396.mp3)

## [prEN ISO/IEC DIS 23282: How to measure whether Natural Language AI is accurate](https://adamleonsmith.substack.com/p/pren-isoiec-dis-23282-how-to-measure)

_2026-06-30 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

What the new NLP evaluation standard covers, and why providers of high-risk and general-purpose AI should read it

## [“We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices](https://podcast.easymedicaldevice.com/395-2/)

_2026-06-25 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

At first glance, hearing “We’ve never had a complaint” sounds like excellent news. No customer dissatisfaction.No product issues.No safety concerns. But for Quality and Regulatory professionals, this statement should trigger \[…\] The post “We’ve Never Had a Complaint” — The Most Dangerous Sentence in Medical Devices appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://ia600501.us.archive.org/10/items/episode-395_202606/Episode%20395.mp3)

## [NC vs CAPA: Are You Opening the Wrong Records?](https://podcast.easymedicaldevice.com/394-2/)

_2026-06-17 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

One of the most common sources of confusion in medical device Quality Management Systems is knowing when to open a Nonconformity (NC) and when to initiate a Corrective and Preventive \[…\] The post NC vs CAPA: Are You Opening the Wrong Records? appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://dn711007.ca.archive.org/0/items/aidp_20260617/aidp.mp3)

## [Best of „AI CE marking“](https://podcast.easymedicaldevice.com/393-2/)

_2026-06-11 · melazzouzi@easymedicaldevice.com (Monir El Azzouzi) · Medical Device made Easy Podcast_

Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the \[…\] The post Best of „AI CE marking“ appeared first on Medical Device made Easy Podcast . hamza benafqir

[Listen](https://ia601908.us.archive.org/4/items/episode-393/Episode%20393.mp3)

## [Two standards, one architecture: FprEN ISO/IEC FDIS 24970 and prEN 18229-1](https://adamleonsmith.substack.com/p/two-standards-one-architecture-fpren)

_2026-06-05 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

Two significant milestones landed this spring serving both the state of the art and Article 12 of the EU AI Act.

## [9 things to look for in compliant agentic AI](https://adamleonsmith.substack.com/p/9-things-to-look-for-in-compliant)

_2026-06-02 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

This article builds on the paper "AI Agents under EU Law" and a keynote presentation I gave to market surveillance authorities in May

## [You can't do AI ethics without AI ethicists](https://adamleonsmith.substack.com/p/you-cant-do-ai-ethics-without-ai)

_2026-06-01 · Enrico PANAI · AI regulation, standards and reality_

EN 18274 approaches publication

## [The Commission reviewed its AI list. Therapy chatbots are the problem it couldn’t classify.](https://adamleonsmith.substack.com/p/the-commission-reviewed-its-prohibited)

_2026-05-29 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

Self-help therapy chatbots are flagged for monitoring.

## [First EU AI Act cases in front of the courts](https://adamleonsmith.substack.com/p/first-eu-ai-act-cases-in-front-of)

_2026-05-25 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

C-806/24 and C-245/25 are the first cases at the CJEU. Here’s what the judges will be deciding.

## [Countdown to Getting Paid (Sponsored)](https://crawlproof.com/a/2Rb5Sl6cWygC)

_2026-05-25 · **Sponsored**_

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## [A general intended purpose includes all high risk use cases by default](https://adamleonsmith.substack.com/p/a-general-intended-purpose-includes)

_2026-05-21 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

The Commission’s guidance on high-risk classification dropped consequential clarification on intended purpose.

## [James Gealy On AI Safety Standards For Frontier Models](https://adamleonsmith.substack.com/p/james-gealy-on-ai-safety-standards-2e7)

_2026-05-20 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

In this episode, hosts Michael Mainelli and Adam Leon Smith welcome James Gealy, Standardization Lead at Safer AI, a French NGO focused on AI risk modelling.

[Listen](https://api.substack.com/feed/podcast/198592137/0013549d75086f9a2f6a978b84326a52.mp3)

## [The Standard that watches the watcher](https://adamleonsmith.substack.com/p/the-standard-that-watches-the-watcher)

_2026-05-20 · Enrico PANAI · AI regulation, standards and reality_

ISO/IEC DIS 25029 and the governance of AI-enhanced nudging

## [The pace is picking up - JTC 21 Timeline Update – May 2026](https://adamleonsmith.substack.com/p/the-pace-is-picking-up-jtc-21-timeline)

_2026-05-15 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

More than half of the standards responding to the EU AI Act are now in public enquiry, or later in the process.

## [prEN 18282 heads to Enquiry: Cybersecurity specifications for AI Systems](https://adamleonsmith.substack.com/p/pren-18282-heads-to-enquiry-cybersecurity)

_2026-05-08 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

The latest harmonised standard to go to public enquiry supports compliance with Article 15

## [What was actually agreed in the Omnibus and what does it mean?](https://adamleonsmith.substack.com/p/what-was-actually-agreed-in-the-omnibus)

_2026-05-07 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

Analysis of the full leaked compromise

## [prEN 18228 heads to Enquiry: the product-safety answer to AI risk management](https://adamleonsmith.substack.com/p/pren-18228-heads-to-enquiry-the-product)

_2026-05-07 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

The draft harmonised standard on AI risk management has reached the CEN Enquiry stage. Here’s what practitioners should notice about how it defines risk, what counts as a risk control, and what to do

## [Mike Thieme On Making AI Standards Work For Busy Professionals](https://adamleonsmith.substack.com/p/mike-thieme-on-making-ai-standards-1a5)

_2026-05-06 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

In this episode, hosts Michael Mainelli and Adam Leon Smith welcome Mike Thieme, Managing Director and Cloud Advisory Lead at Accenture.

[Listen](https://api.substack.com/feed/podcast/198592138/00e20770ea14f64d911b192438a771a4.mp3)

## [ISO/IEC 25059 gets a rewrite: AI quality models expand beyond the product](https://adamleonsmith.substack.com/p/isoiec-25059-gets-a-rewrite-ai-quality)

_2026-05-04 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

The SQuaRE quality model for AI systems revision completes enquiry

## [Play Both Sides Of The Lie (Sponsored)](https://crawlproof.com/a/RE1jblLJnP30)

_2026-05-04 · **Sponsored**_

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## [AI Agents Under EU Law: what providers actually have to do](https://adamleonsmith.substack.com/p/ai-agents-under-eu-law-what-providers)

_2026-05-02 · Adam Leon Smith DEng FBCS · AI regulation, standards and reality_

High-risk agentic systems with untraceable behavioural drift cannot currently satisfy the essential requirements of the AI Act