Insights on Medical Device Quality and Regulatory Affairs

ISO 13485 is the foundation of quality management for medical device companies. In this first article of our ISO 13485 Explained series, we explore what the standard is, why it matters, and how it helps organizations build a practical and compliant Quality Management System.

FDA’s 2026 Human Factors guidance clarifies what information should be included in medical device submissions. Here’s what changed, what the new HF Submission Categories mean, and why it matters.

Implantable medical devices face some of the strictest regulatory requirements under MDR and FDA frameworks. This article explores clinical evaluation, PMCF, risk management, technical documentation, cybersecurity, and regulatory strategy for implantable medical devices.

Many manufacturers still treat Post-Market Surveillance (PMS) as a regulatory checkbox. That approach doesn’t hold anymore. Under the EU MDR, PMS is a structured and mandatory framework for all medical device classes. It requires continuous, proactive data collection and evaluation throughout the product lifecycle. On the FDA side, the terminology may differ, and a formal […]

ISO 13485 certification pathway: what it really takes to get certified a step-by-step guide for medical device companies Getting ISO 13485 certified sounds like a structured process. In reality, most companies realise it’s not about following steps it’s about building a system that actually works. What ISO 13485 certification actually means Before going into the […]

When developing software for medical devices, understanding IEC 62304 is crucial. This international standard not only ensures safety and compliance but also significantly reduces regulatory delays and costly rework. With a focus on risk-based thinking, IEC 62304 guides the entire software lifecycle—from planning and architecture to verification and maintenance. By implementing structured processes, companies can demonstrate safety and performance effectively. Discover how integrating IEC 62304 into your development process can transform your approach to medical device software and safeguard patient health. Read on to learn more about the essential principles and practices of IEC 62304.

What is Quality Manager as a Service? In the medical device industry, quality and regulatory requirements are not optional. Standards such as ISO 13485, the EU Medical Device Regulation (MDR), and the FDA QMSR require companies to build structured quality management systems and maintain proper technical documentation throughout product development. For many MedTech startups and growing companies, […]

Internal audits are more than a checkbox exercise. Learn how medical device companies can use internal audits to ensure ISO 13485 compliance, prepare for EU MDR, and improve operational efficiency

The “Class I” Trap: Why Simple Doesn’t Mean Easy When companies hear “EU MDR Class I,” the reaction is usually one of relief. It’s often viewed as the regulatory equivalent of a “fast pass”. No Notified Body (in most cases), less paperwork, and a quicker sprint to market. Many assume this means they can skip […]

FDA Pathways for Medical Devices are not just regulatory checkboxes. They define how your product enters the U.S. market and shape your entire business strategy from day one. Entering the U.S. market is not just a regulatory milestone. It is a strategic decision that defines your testing plan, clinical and performance evidence, risk management, timeline, […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]