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In the ever-evolving landscape of healthcare, the development and deployment of cutting-edge medical devices have become indispensable. 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.

In the fast-paced world of medical device manufacturing, regulatory standards are the bedrock of patient safety and product quality. Recently, the European Union has taken a significant step by extending Article 120 of the EU Regulation 2017/745 and EU Regulation 2017/746. This move has been made to address the mounting backlog of CE mark certifications and re-certifications within notified bodies, the entities responsible for ensuring that medical devices meet stringent quality and safety requirements before they reach the market. In this blog post, we’ll delve into the implications of this extension for medical device manufacturers and emphasize the critical importance of continued compliance.

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.

In the realm of healthcare, artificial intelligence (AI) is not just a buzzword; it’s 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.

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.

In today’s rapidly evolving healthcare landscape, ensuring the safety and effectiveness of medical devices is of paramount importance. To address this, the European Union (EU) has implemented the European Database on Medical Devices (EUDAMED). EUDAMED is a comprehensive and centralized system designed to enhance transparency, facilitate regulatory processes, and improve patient safety across the EU. …

EUDAMED: Enhancing Transparency and Safety in Medical Device Regulation Read More »

Quality assurance (QA) and quality control (QC) are two important concepts in the medical device industry. Although they are related, there are distinct differences between the two. In this blog post, we will explore the difference between medical device quality assurance and quality control.  What is medical device Quality Assurance? Medical device quality assurance (QA) …

Quality Assurance & Quality Control Read More »

Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.

One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally

Medical devices must be of high quality to be considered safe on the market. Strict safety and quality regulations must be met to achieve this. In this article, we’re answering the question – what is ISO 13485? What is ISO 13485? ISO 13485 is an international standard for mapping what is required from a medical …

What is ISO 13485? Read More »

Medical devices are essential pieces of equipment, and there are a lot of them out there on the market. In this blog, we’re looking at the importance of medical device registration. What are medical devices? Medical devices range from any instrument, medical software or medical equipment used by healthcare professionals. The medical industry can be …

What is the importance of medical device registration? Read More »