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Implementing a Quality Management System (QMS) is a critical step for any medical device company. But as many organizations learn the hard way, QMS implementation is not just about drafting procedures - it’s about creating a functional system that aligns with your company’s processes, resources, and risk profile. In this article, we’ll walk through common pitfalls that medical device companies face during QMS implementation - and more importantly, how to avoid them.

Turning Compliance into Continuous Improvement in Medical Device Quality Systems Under ISO 13485:2016, CAPA is a required element of every quality management system (QMS) - and it's often a focal point during audits and inspections. But here's the reality: many companies treat CAPA as a reactive, check-the-box activity. The result? Repeated issues, minimal learning, and limited improvement. In this article, we’ll explore how to build and manage a CAPA system that not only meets ISO 13485 requirements but strengthens your organization

Understanding the Risk Management File under ISO 13485 and ISO 14971 In the world of medical device manufacturing, patient safety is non-negotiable. To meet international standards like ISO 13485 and ISO 14971, you’ll need a structured, ongoing approach to risk management throughout the product lifecycle. At the heart of this process is the Risk Management File (RMF) - a critical document that captures how safety-related decisions are made, justified, and maintained. In this article, we’ll break down the key sections of the Risk Management File, explain their purpose, and share tips for keeping your file compliant, audit-ready, and integrated with your quality management system (QMS).

Following the European Union Medical Device Regulation (EU MDR 2017/745), maintaining a compliant and well-structured Technical Documentation (TD) file is one of the most critical requirements for manufacturers. This file forms the backbone of regulatory conformity and is subject to thorough review by notified bodies and competent authorities. Whether you're placing a Class I product on the market or preparing a Class III device for CE marking, the structure of your technical file plays a vital role in demonstrating compliance, ensuring traceability, and streamlining regulatory submissions. In this article, we’ll break down the key components of an EU MDR-compliant Technical File and provide practical guidance on organizing it effectively.

At the core of every successful Quality Management System (QMS) lies a robust document control process. According to ISO 13485:2016, controlling documents is a foundational requirement for maintaining compliance, ensuring product quality, and supporting patient safety. Poor document control can lead to outdated procedures, inconsistent work practices, audit findings, or even regulatory penalties. But when implemented correctly, document control becomes a powerful tool for maintaining order, ensuring accuracy, and enabling continuous improvement. In this article, we’ll explore the ISO 13485 requirements for document control, share best practices, and offer practical tips for optimizing document management in your QMS.

A Guide for Medical Device Companies in Line with ISO 13485 Among the core requirements of ISO 13485, internal audits play a vital role. They help ensure that processes meet regulatory and customer requirements, uncover nonconformities, and drive continuous improvement. In this article, we’ll explore how to plan, conduct, and follow up on internal audits in a way that aligns with ISO 13485:2016 and supports a culture of quality and compliance.

If you are a medical device manufacturer operating under the EU MDR, you are likely familiar with the Periodic Safety Update Report (PSUR). But what exactly is its role, and how can it support both compliance and clinical oversight? The PSUR is a key element of your post-market surveillance system, offering structured, periodic insight into the real-world performance and safety of your device. Rather than being a regulatory formality, it plays a vital part in ensuring the continued acceptability of your device's benefit-risk profile. In this brief article, we explore what the PSUR is, when it is required, what it should contain — and how to ensure it delivers value beyond compliance.

For both startups and established manufacturers, early engagement with the FDA can reduce risk, improve submission quality, and accelerate time to market. One of the most effective tools for doing this is the Q-Submission (Q-Sub) Program. In this brief article, we’ll explain what a Q-submission is, when it should be used, how to prepare one effectively — and how our team at CitoQualis can help you get it right.

If you manufacture Class III or implantable medical devices in the EU, the Summary of Safety and Clinical Performance (SSCP) is a regulatory requirement under MDR 2017/745. But what is the purpose of the SSCP, and how do you make sure yours supports both compliance and usability? The SSCP is designed to improve transparency for healthcare professionals and, where relevant, for patients. It provides accessible, high-level information on your device’s safety and clinical performance in a way that’s clear, accurate, and traceable to your technical documentation. In this brief article, we explore what the SSCP is, what it must contain, and how to create one that’s both compliant and effective.

Risk management is a critical process in the lifecycle of a medical device, ensuring that products are designed and maintained with patient safety and regulatory compliance in mind. ISO 14971, the internationally recognized standard for medical device risk management, provides a structured framework to identify, evaluate, and control risks. At the heart of this process lies the risk analysis—an organized approach to understanding potential harm. In this brief article, we break down the core elements that make up a risk analysis per ISO 14971. This post is perfect for anyone who wants to build safer products without getting lost in technical jargon.

In the medical device industry, ensuring patient safety isn't just ethical — it's a regulatory requirement. ISO 14971, the international standard for medical device risk management, defines a comprehensive framework to identify, evaluate, control, and monitor risks throughout the product lifecycle. In this article, we provide a clear and practical breakdown of the ISO 14971 risk management process general steps :

What happens to your medical device once it hits the market? That’s no longer a question that manufacturers can afford to overlook. Under the EU Medical Device Regulation (MDR) 2017/745, Post-Market Clinical Follow-Up (PMCF) has become a central, ongoing requirement for ensuring the continued safety and performance of medical devices. It’s not just a task at the end of development — it’s part of a lifecycle approach to clinical evidence and compliance. In this brief article, we explore what PMCF is, why it matters, and how to implement it in a way that supports both MDR compliance and your broader regulatory strategy.

How well do you really know your device once it’s on the market? Under the EU Medical Device Regulation (MDR) 2017/745, Post-Market Surveillance (PMS) has become more than a routine task — it’s now a core regulatory requirement with stricter expectations, deeper documentation, and closer scrutiny from Notified Bodies. PMS is no longer just a reactive process focused on complaints or vigilance reporting. Manufacturers are now expected to establish a proactive, systematic PMS system that continuously monitors the real-world performance, safety, and benefit-risk profile of their device — and to document it with traceable plans, reports, and updates. In this article, we’ll break down what PMS is, how MDR has raised the bar, and what manufacturers must do to stay compliant and ahead of risk.

Have you ever considered that a perfectly functioning medical device can still fail if users can’t use it safely or effectively? Usability has become a core element of medical device development, directly impacting regulatory approval, user safety, and real-world effectiveness. In this article, we explore what usability engineering is, which regulations and standards apply, and how to effectively integrate usability into your device development process from day one.

Navigating regulatory requirements in the medical device industry can be challenging, especially when dealing with multiple countries. The Medical Device Single Audit Program (MDSAP) was developed to reduce this burden by allowing manufacturers to undergo a single audit of their quality management system (QMS) to meet the regulatory requirements of five major markets. While MDSAP does not replace product approvals, it streamlines QMS audits across borders. In this brief blog article, we explore what MDSAP is and how it can benefit your organization.

Bringing a medical device to market is more than innovation—it’s a balance between potential benefits and risks. Whether you’re developing a Class I wound dressing or a life-sustaining Class III implant, you must prove that your device is not only effective but also safe. That’s where Benefit-Risk Analysis comes in. This critical evaluation is at the heart of regulatory submissions in both the European Union (EU) and the United States, and it’s a key expectation of international standards like ISO 13485. In this short article we break down what Benefit-Risk Analysis means—and what regulators are looking for.

This article explores the key challenges posed by Article 61 MDR, the essential steps in clinical evaluation, and the best practices for manufacturers to ensure compliance.

ISO 13485 is the international standard for quality management systems (QMS) in the medical device industry. Ensuring compliance with this standard is crucial for manufacturers aiming to produce safe and effective medical devices. In this short article, we provide a step-by-step guide to help your organization navigate the path to ISO 13485 certification.

Are you a medical device manufacturer looking to navigate the complexities of European regulatory compliance? Understanding the General Safety and Performance Requirements (GSPR) is crucial for ensuring that your device meets the stringent safety, performance, and risk management standards required under the European Union’s Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). This brief blog article explores the GSPR framework, its significance, and how manufacturers can achieve compliance

This is a question that many manufacturers face when determining the extent of biological evaluation necessary for their products. In this brief article we explain the basic concepts and regulatory requirements.

The MDCG 2023-3 Rev.2 guide, updated in January 2025, provides significant clarifications and adjustments to help medical device (MD) and in vitro diagnostic device (IVD) manufacturers comply with MDR (2017/745) and IVDR (2017/746) regulations. This article analyses the main new points included in the Revision 1 and 2 versions:

In the context of the European Union’s Medical Device Regulation (EU MDR), the Person Responsible for Regulatory Compliance (PRRC) plays a critical role in ensuring that medical devices are compliant with regulatory requirements before they hit the market and throughout their lifecycle. The PRRC must have the necessary expertise and responsibilities to monitor ongoing compliance with safety, quality, and regulatory standards.

In the highly regulated and rapidly evolving medical device industry, effective supplier management is crucial for ensuring product quality, compliance, and overall business success. Medical device manufacturers must navigate complex supply chains, adhere to stringent regulatory requirements, and maintain high standards of safety and efficacy. In this article, we will explore the key aspects of supplier management.

In today’s fast-paced technological landscape, medical devices organizations are increasingly reliant on sophisticated software and computer systems. Ensuring that these systems operate correctly and produce reliable results is ultimately crucial for ensuring patient safety and regulatory compliance. In this article, we’ll briefly explore what Computer System Validation (CSV) is, how it aligns with industry standards and the key steps to consider.

"A process that an organization needs for its quality management system and which the organization chooses to have performed by an external party". This includes processes for management activities, provision of resources, product realization and measurement, analysis and improvement.

If you’re launching a medical device startup, you’re probably focused on innovation, design, and bringing your product to market. But there’s one key ingredient that could make or break your success - quality management. You might be thinking, “Isn’t that just for big companies?” The truth is, whether you're a small team or a growing company, establishing a Quality Management System (QMS) is essential for long-term success. Let’s break down why a QMS isn’t just a box to check—it's a vital part of your roadmap to safety, compliance, and customer satisfaction.

A common question we receive from clients is: When is the right time to start documenting for a medical device project, and what documentation should we begin with? For those experienced in regulatory and quality processes, the answer is clear: documentation should begin as early as possible in the project lifecycle. Here’s why early documentation is critical, and how companies, especially young start-ups, can approach it effectively.