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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?

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 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 »

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

Blog, EU Regulations, UK Regulations, USA Regulations /

Medical device registration is an essential part of 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. 

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

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

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 a file with a cog and lines above it representing text. The cog represents technical information. The image is used by patient guard limited to discuss medical device technical files (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 »

medical device post market surveillance.

Post Market Surveillance – Medical Devices

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Quality Management, UK Regulations /

Post-market surveillance (PMS) is a pivotal aspect that governs the continued monitoring and assessment of medical devices after they have entered the market. Across the EU, UK, and USA, distinct regulatory frameworks shape PMS protocols, fostering safety, and innovation simultaneously.

Post Market Surveillance – Medical Devices Read More »

IVD regulatory consultancy offered by Patient Guard in relation to the IVDR 2017/745

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746

Blog, EU Regulations, Guides and Advice /

In the ever-evolving landscape of healthcare, in vitro diagnostic (IVD) devices are indispensable tools, providing invaluable insights into patients’ health conditions. With the introduction of Regulation (EU) 2017/746, commonly known as IVDR, the European Union has implemented stringent regulations to ensure the safety, efficacy, and quality of these diagnostic instruments. As of May 26, 2022, this regulation has ushered in a new era, shaping the practices of manufacturers, healthcare professionals, and patients as they navigate the complexities of this comprehensive regulatory framework.

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746 Read More »

medical device consultants can help with global regulatory requirements ensuring medical device compliance

Medical Device Consultancy – Patient Guard leads the way

Blog, Patient Guard News /

Medical Device Consultancy provides tailored expertise to your business, helping to navigate the medical device industry.

With advancements in technology, the need for stringent regulatory and quality assurance services has never been more crucial. In this dynamic environment, medical device consultancy plays a pivotal role, guiding innovators through the complex web of regulations, ensuring compliance, and facilitating the delivery of safe and effective devices to patients worldwide.

Medical Device Consultancy – Patient Guard leads the way Read More »

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Medical Device Software and AI – Revolutionizing Healthcare

Blog, Client Questions /

Medical Device Software and artificial intelligence (AI) are not just buzzwords; AI is a transformative force that is reshaping the landscape of medicine and medical technology. Over the past decade, we have witnessed remarkable advancements in AI, and its impact on the medical device industry is nothing short of revolutionary. As we step into the next five years, the synergy between AI and medical devices is poised to usher in a new era of healthcare innovation, efficiency, and patient outcomes.

Medical Device Software and AI – Revolutionizing Healthcare Read More »

EUDAMED - European Database on Medical Devices

EUDAMED: European Database on Medical Devices

Blog, EU Regulations, Quality Management, Standards /

EUDAMED stands for the European Database on Medical Devices. It is a secure, web-based platform established by the EU to collect, store, and disseminate information related to medical devices available in the European market. The primary objective of EUDAMED is to centralize and harmonize data on medical devices, manufacturers, and notified bodies throughout the EU member states. 

EUDAMED: European Database on Medical Devices Read More »

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