Patient Guard


Ensuring medical device users can operate medical devices safely and easily is of vital importance to reduce user errors IEC 62366 provides a framework for medical device manufacturers to develop safe medical devices with the user in mind.

IEC 62366-1 Usability Engineering and its use in Medical Device Design and Development

In medical device design, the efficacy, safety, and user experience is paramount. While the technical function of a device is unquestionably significant, its usability can often determine its real-world impact. This is where standards like IEC 62366-1 come into play, offering a structured approach to integrating user-centred design principles into the development process. In this blog, we’ll delve deeper into the significance of IEC 62366-1, its underlying principles, practical implementation strategies, and the broader implications for medical device innovation and patient care.

IEC 62366-1 Usability Engineering and its use in Medical Device Design and Development Read More »

illustration of a male and female doctor - this is used by patient guard for discussing medical device clinical evaluation.

Understanding Medical Device Clinical Evaluation

All Medical Devices that are placed on the market in the EU and the UK must undergo Clinical Evaluation. Clinical Evaluation is a review of all the data that has been generated by the medical device manufacturer; pre-clinical, clinical and post market. The review of this data is performed to assess that the benefits of using the medical device outweigh the risks associated with using the medical device within the devices clinical intended purpose. 

Understanding Medical Device Clinical Evaluation Read More »

The image shows a digital screen with light up in blue against a dark background are icons such as a tick, and a pad with a pencil next to it. The icons are in hexagons. In other light up hexagons are the words Quality Assurance . This image is used by Patient Guard to talk about their Medical Device and IVD Quality Assurance Services.

Medical Device QA Support: What are the benefits?

In today’s fast-paced and highly competitive business environment, ensuring the quality of your Medical Device products and services is paramount. Professional Quality Assurance (QA) support is the unsung hero that can help your business thrive. Whether you’re a start-up or an established enterprise, effective QA support can make a significant impact on the quality of your Management System and Devices. In this blog post, we’ll explore how professional QA support can benefit your business.

Medical Device QA Support: What are the benefits? Read More »

The image shows medical devices placed on a table - This is used to indicate that Patient Guard is a Medical device regulatory and quality assurance consultancy

Understanding IEC 62304: A Comprehensive Guide to Medical Device Software Lifecycle Processes

In the ever-evolving landscape of healthcare technology, medical device software plays a pivotal role in patient care. To ensure the reliability, safety, and effectiveness of these software-driven devices, regulatory standards are in place. One such crucial standard is the IEC 62304. In this blog, we will delve into the intricacies of IEC 62304, exploring its significance, key concepts, and its impact on the development of medical device software.

Understanding IEC 62304: A Comprehensive Guide to Medical Device Software Lifecycle Processes Read More »

The risk management of medical devices following ISO 14971

ISO 14971 and the Risk Management of Medical Devices

In the world of medical devices, ensuring both safety and compliance with industry standards is paramount. One such crucial standard is ISO 14971, a guideline that outlines the application of risk management to medical devices. In this blog post, we will delve into the significance of ISO 14971 in medical device compliance and explore how tools like Patient Guard can aid in achieving and maintaining compliance with this essential standard.

ISO 14971 and the Risk Management of Medical Devices 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?

ISO 13485 is an international standard for mapping what is required from a medical device. The system ensures that medical devices are effective and consistent throughout their life cycle, from planning and production to disposal.

Ensuring consistency is extremely important for medical devices, as patient safety could be at risk. Implementing quality management systems can also provide protection for manufacturers and their reputations, as risks can be easily identified and rectified.

Medical device regulation varies based on the classification of the medical device being manufactured. All parties are required to demonstrate compliance, from the medical device manufacturing process to the disposal of the product.

What is ISO 13485? Read More »

Animation picture of a thermometer and surgical tools with the phrase "medical device?" underneath the pictures.

Is Your Product a Medical Device?

In the rapidly evolving landscape of product development, especially within the health and wellness sector, it’s crucial for developers and manufacturers to understand the regulatory implications of their innovations. One burning question that often arises is, “Is my product a medical device?” The classification of a product as a medical device carries significant regulatory and legal implications, impacting market access, safety standards, and compliance requirements. In this blog, we’ll explore the criteria that determine whether a product falls into the medical device category and shed light on the importance of regulatory compliance in this complex field.

Is Your Product a Medical Device? Read More »

image of a colourful world map - used by patient guard limited on their blog about global medical device and IVD registrations.

Medical Device & IVD registration

Commercialising your medical device or IVD first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies. 

Depending on where you plan to sell your device(s), successful registration may involve a substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.

Medical Device & IVD registration Read More »

Medical Device Life Cycle following the Plan, Do, Check, Action model. Used by patient guard to explain medical device design and development life cycle which start with medical device regulations, then standards, then design inputs, then risk management, then design outputs, prototypes, design verification and validation, manufacturing specifications and finally design history, before the cycle starts again at regulations.

Medical Device Design and Development

Planning for the design and development of a medical device is a requirement of regulatory systems. All manufacturers of Medical Devices are required to maintain a Quality Management System, in the USA this is determined under the CFR Title 21 part 820. Within the European Union, it is placed within demonstrating certificated compliance with international standard EN ISO 13485. The USA has recently indicated that they will also use the ISO 13485 standard for the requirements of manufacturers being compliant for QMS purposes. 

Medical Device Design and Development Read More »

image of lightbulb with hexagons sound it on bothsides with icons representing medical device supply chain, the light bulb is being held in a doctors hands who is in blue scrubs - the image is used by patient guard for its medical device and IVD CE mark and IVD marking related product services.

CE Marking Medical Devices

The CE marking of medical devices and in vitro diagnostic devices (IVDs) is a requirement of EU regulations (EU 2017/745 for medical devices and EU 2017/746 for IVDs) to lawfully place medical devices on the EU market. Manufacturers must affix the CE mark on the medical device or IVD itself and on the primary packaging (or just on the packaging if affixing to the device itself it not possible). The CE mark should also be placed on any instructions for use and any labelling. The use of the CE mark identifies that a medical device or IVD conforms to EU regulatory requirements and is a symbol that a device meets safety standards.

CE Marking Medical Devices Read More »

Do you need support with Medical Device or IVD compliance?

We can help you!