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drug Infusion bag

Drug Stability in Medical Devices: Syringes, Infusion Sets and Bags

Blog, EU Regulations, Guides and Advice, Medical Device Pre-launch, Medical Device Validation, USA Regulations /

Ensuring the stability of drugs in contact with medical devices such as syringes, infusion administration sets and infusion administration bags is paramount. This article delves into the importance of drug stability testing, the challenges faced, and the methodologies employed to guarantee that the drugs administered through these devices remain safe and effective.

Drug Stability in Medical Devices: Syringes, Infusion Sets and Bags Read More »

E&L Testing in medical devices

ISO 10993 Extractables and Leachables Testing: Chemical Characterisation and Toxicological Risk Assessment

Blog, EU Regulations, Medical Device Pre-launch, Medical Device Validation, Standards, USA Regulations /

In medical device design and development and manufacturing, ensuring the safety and biocompatibility of products is paramount. As part of the biological evaluation process, extractables and leachables (E&L) testing plays a crucial role. This testing ensures that any chemicals that might migrate from the device materials into the body do not pose a risk to patients. The ISO 10993 standard series provides comprehensive guidelines for the biological evaluation of medical devices, including protocols for E&L testing. In this blog, we will delve into the importance of extractables and leachables testing, its procedures, and its relevance within the ISO 10993 framework.

ISO 10993 Extractables and Leachables Testing: Chemical Characterisation and Toxicological Risk Assessment Read More »

Patient Guard hero image illustrating the core elements of an ISO 13485 Quality Management System, including leadership, document control, risk management, design and development, supplier management, validation, internal audits, CAPA and continual improvement for medical device manufacturers.

Understanding the core elements of Quality Management Systems

Blog, Quality Assurance, Quality Management, Standards, USA Regulations /

In today’s competitive marketplace, delivering high-quality products and services is essential for business success. A Quality Management System (QMS) is a structured framework that helps organizations ensure they meet customer requirements and enhance customer satisfaction. But what are the fundamental elements that constitute a robust QMS? In this blog, we will explore the basic components that form the backbone of effective quality management systems.

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Hero image comparing ISO 13485 and the FDA Quality System Regulation (21 CFR Part 820/QMSR), illustrating the key differences between international and US medical device quality management systems, including risk management, design controls, documentation, supplier management and regulatory compliance.

5 Differences Between ISO 13485 & FDAs Medical Device QSR

Blog, Quality Assurance, Quality Management, Standards, USA Regulations /

Medical device manufacturers face a daunting task: navigating complex regulatory landscapes to ensure their products meet safety and quality standards. In order to sell products in the US, manufacturers are required to comply with CFR 21 Part 820, whereas for global markets, the voluntary ISO 13485 is used. These two standards are not the same, and companies must understand the differences between them if they are to get their products to market across regions. However, with the FDA actively working to align CFR 21 Part 820 more closely with ISO 13485, the effort toward global harmonization is a promising sign for medical device manufacturers.

5 Differences Between ISO 13485 & FDAs Medical Device QSR Read More »

Hero image illustrating IEC 62366-1 usability engineering for medical devices, showing healthcare professionals evaluating a medical device to support user-centred design, human factors engineering, usability testing, risk management and patient safety throughout the product lifecycle.

IEC 62366-1 Explained: Medical Device Usability Engineering Guide

Blog, Guides and Advice, Medical Device Pre-launch, Medical Device Validation, Standards /

Learn how IEC 62366-1 helps medical device and IVD manufacturers design safer, more intuitive products through usability engineering. Discover the usability engineering process, human factors, formative and summative evaluations, usability files and regulatory expectations under the MDR, IVDR and FDA.

IEC 62366-1 Explained: Medical Device Usability Engineering Guide Read More »

Regulatory workspace illustrating EU MDR Article 120 transitional provisions, featuring a transition timeline, key MDR deadlines calendar, Regulation (EU) 2017/745 open to Article 120, legacy medical device technical documentation, ISO 13485 Quality Management System files, CE-marked medical device packaging, transition compliance checklist and project plan for MDR compliance.

EU MDR Article 120 Explained: Transitional Provisions and Extended Deadlines

Blog, EU Regulations, Guides and Advice, Patient Guard News, Standards /

Article 120 of the EU Medical Device Regulation (MDR) introduced transitional provisions allowing certain legacy devices to remain on the market beyond the original MDR application date. However, these extended deadlines are only available to manufacturers that satisfy specific regulatory conditions. This guide explains how Article 120 works, which devices qualify, the current transition deadlines, what constitutes a significant change, and the practical steps manufacturers should take to maintain compliance under the EU MDR.

EU MDR Article 120 Explained: Transitional Provisions and Extended Deadlines Read More »

Medical device Quality Assurance specialist supporting ISO 13485 compliance through Quality Management Systems, risk management, audit readiness and regulatory compliance.

Medical Device Quality Assurance Support: Why Outsourcing ISO 13485 Expertise Makes Sense

Blog, Client Questions /

Quality Assurance (QA) plays a critical role in ensuring medical devices remain safe, effective and compliant throughout their lifecycle. Whether you are implementing ISO 13485, preparing for MDR or IVDR certification, responding to audit findings or scaling your business, outsourced QA support provides the expertise needed to maintain regulatory compliance without the cost of a full-time quality department.

Medical Device Quality Assurance Support: Why Outsourcing ISO 13485 Expertise Makes Sense Read More »

A certificate that says 'ISO 13485 certified' on it - This image is used by patient guard to represent ISO 13485 quality assurance and QMS services.

What is ISO 13485? The Complete Guide to Medical Device QMS

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Standards, UK Regulations, USA Regulations /

ISO 13485:2016 is the international standout standard that defines the precise requirements for a Quality Management System (QMS) specific to the medical device industry. Unlike general business quality frameworks, it prioritizes patient safety, clinical efficacy, and global regulatory compliance ahead of standard consumer satisfaction metrics.

Whether you are an active medical device manufacturer, a software-as-a-service (SaMD) developer, an importer, or an EU/UK distributor, demonstrating compliance with this standard is virtually mandatory to secure and retain critical market access.

What is ISO 13485? The Complete Guide to Medical Device QMS Read More »

Infographic illustrating the different medical device registration pathways for the European Union, United Kingdom and international markets, showing the relationship between CE marking, EUDAMED registration, UDI assignment, MHRA registration, UK Responsible Person, Authorised Representative and international regulatory registrations including FDA and ARTG.

Medical Device Registration Explained: EU, UK and Global Requirements

Blog, EU Regulations, UK Regulations, USA Regulations /

Medical device registration is not a single regulatory process. Depending on where you intend to market your medical device or IVD, you may need CE marking, MHRA registration, EUDAMED registration, UDI assignment or an Authorised Representative. This guide explains the different registration requirements under the EU MDR, IVDR and UK regulations, helping manufacturers understand which obligations apply before placing their products on the market.

Medical Device Registration Explained: EU, UK and Global Requirements Read More »

Hero image illustrating the structure of a medical device technical file under the EU MDR, showing the key documentation required for CE marking, including device description, General Safety and Performance Requirements (GSPRs), Risk Management File, verification and validation, Clinical Evaluation, Biological Evaluation and Post-Market Surveillance in accordance with Regulation (EU) 2017/745.

How to Structure a Medical Device Technical File

Blog, EU Regulations, Guides and Advice, Medical Device Pre-launch, UK Regulations /

A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and safety of a particular Medical Device in a clear, well-organized, easily searchable, and unambiguous manner.

In order to prove compliance with the general safety and performance criteria of the legislation, the manufacturer must have – and keep up-to-date – this technical documentation, regardless of  medical device class.

How to Structure a Medical Device Technical File Read More »

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