Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes.

In this podcast episode, we provide a structured and practical discussion on:

The definition and purpose of a DHF

Key differences between FDA QMSR and ISO 13485 requirements

How the DHF concept is addressed within ISO 13485

When DHF remediation becomes unavoidable

Typical causes of remediation, including accumulated DHF debt

How to remediate a DHF without creating new compliance risks

Common pitfalls and practices to avoid

How to define a realistic and defensible remediation strategy

Regulatory communication considerations with:

National Competent Authorities

Notified Bodies

This episode is based on an article developed by Wega Informatik AG and is intended to help MedTech professionals approach DHF remediation in a controlled, transparent, and compliant way.

If you are responsible for design controls, quality systems, or regulatory compliance, this episode will help you avoid costly mistakes and build confidence in your remediation approach.

Links

Richie Christian Linkedin: https://www.linkedin.com/in/christianrichie/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many teams.

In this podcast episode, we sit down with Aaron Joseph, medical device development expert and author of the well-known article “Top 10 V&V Fails”, to explore why V&V so often becomes a source of stress — and how teams can do better.

Throughout the discussion, we cover:

A clear, simple explanation of Verification vs. Validation

Why V&V must span the entire development lifecycle

How poor requirements create downstream V&V failures

The risks of starting V&V planning too late

How to simplify test methods without losing rigor

Practical strategies for handling failed tests

How to think about traceability without fear

The future of V&V as software and AI become more prevalent

This episode is designed to educate, demystify, and inspire QA/RA professionals, engineers, and MedTech leaders looking to build stronger, more resilient development processes.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Social Media to follow

Aaron Joseph Linkedin: https://www.linkedin.com/in/ajosephprofile/

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

As the year closes, this special podcast episode offers a comprehensive overview of what happened at Easy Medical Device in 2025 and the key priorities shaping 2026.

The episode reflects on a full year of continuous content creation, including:

Weekly podcast episodes covering global medical device regulations

Increased focus on artificial intelligence and its impact on QA/RA roles

Educational initiatives such as EMD Mag, designed to make complex regulatory topics more accessible

Development of digital tools like EasyIFU, labeling automation, and eQMS solutions

Expansion of consulting, back-office services, and international presence

The discussion also addresses upcoming challenges:

Increasing pressure on Notified Bodies

Risks for late MDR/IVDR transitions

The importance of anticipation and regulatory strategy for new and existing manufacturers

More than a recap, this episode is a strategic pause — an opportunity to reflect, learn, and prepare for the years ahead in a rapidly evolving medtech regulatory environment.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

The European medical device sector is a vital pillar of healthcare innovation, employing over 930,000 people and representing a market of approximately €170 billion. However, since the implementation of MDR and IVDR, manufacturers—especially SMEs—have faced increasing regulatory complexity, long certification timelines, and reduced market predictability.

In this podcast episode, we explore the 2025 EU proposal designed to address these challenges by simplifying regulatory processes while preserving patient safety.

The discussion covers:

Key shortcomings of the current MDR/IVDR framework

The impact on innovation, availability of devices, and SMEs

The eight reform pillars, including proportionality, digitalisation, international cooperation, and improved coordination with EMA and Notified Bodies

How upcoming EU legislation (AI Act, Cybersecurity Act, Biotech Act) will interact with medical device regulations

This episode provides practical insights for manufacturers, regulatory professionals, and policymakers seeking to anticipate regulatory changes and adapt their strategies accordingly.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

Adam Linkedin: https://www.linkedin.com/in/adam-isaacs-rae/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter:

https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

Clinical Evaluation has become one of the most critical — and challenging — domains under the EU MDR. But how does one build real expertise in this field?

In this episode of the Medical Device Made Easy podcast, Monir El Azzouzi interviews Florian Tolkmitt, Clinical Evaluation Expert at Pro-Liance, to explore his journey from engineering into clinical evaluation and regulatory science.

The discussion covers:

Florian’s education and early career path

How he specialized in Clinical Evaluation

Key lessons learned since the implementation of the EU MDR

What Notified Bodies really expect from clinical documentation

Frequent mistakes manufacturers make in clinical submissions

The evolving role of consultants in supporting compliance

How AI and digital tools may transform literature review and evidence generation

Advice for young professionals entering the MedTech field

This episode offers practical insights, career inspiration, and forward-looking perspectives for anyone working — or aspiring to work — in clinical evaluation and regulatory affairs.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links

Linkedin florian: https://www.linkedin.com/in/florian-tolkmitt-clinical-evaluation/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

Becoming a Lead Auditor is one of the most valuable career steps for quality and regulatory professionals in the MedTech sector. Lead Auditors play a critical role in evaluating QMS performance, improving compliance, and preparing organizations for ISO certification.

In this podcast episode, we explore:

🔹 What is a Lead Auditor?

The responsibilities, authority, and role differences between internal audits, supplier audits, and certification audits.

🔹 Who can become a Lead Auditor?

The competencies required, background expectations, and what makes a good auditor.

🔹 What you must learn to be effective:

ISO 19011 — the core auditing guideline

ISO 13485 — the medical device QMS standard

ISO 14971 — risk management for medical devices

Software lifecycle & technical documentation considerations

🔹 Do Lead Auditor certificates expire?

Clarifying the myth around renewal, competency maintenance, and the expectations of certification bodies.

🔹 Spotlight: Lead Auditor Training by Medical Device Academy

We review the upcoming training course, covering:

Curriculum and learning objectives

Exam format

Prerequisites

Pricing

Training dates

Certificate details

👉 Learn more or register here: https://medicaldeviceacademy.com/lead-auditor-training/

This episode is ideal for QA/RA specialists, QMS managers, consultants, and anyone aiming to take a leadership role in medical device auditing.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice