Electrical safety in medical devices is important to ensure that users of electronic medical device equipment are not subject to electrical risks. Medical Device manufacturers must ensure that their electronic devices are safe and that any risks are as low as possible.
Electrical Safety in Medical Devices Read More »
Medical Device Sterilization is a key aspect of ensuring certain Medical Devices are safe and effective. Sterilization ensures that the medical device is free from microorganisms before they are used on patients. Reducing the risk of infections.
Medical Device Sterilization Read More »
Software as a Medical Device (SaMD) has fundamentally changed the clinical landscape. From AI-driven diagnostic image scanning to standalone smartphone apps used for real-time clinical decision-making, digital health tools are scaling faster than ever. However, understanding exactly how SaMD is regulated, classified, and maintained is critical to securing market access under current MHRA and EU Notified Body expectations.
Software as a Medical Device (SaMD): Regulatory & Development Guide Read More »
When developing a new and exciting product it can be hard to know if it might fall under specific regulations. This is usually the case with medical devices. The medical device industry is highly regulated worldwide. These regulations have specific criteria that determines if a product falls under the definition of a medical device. Therefore it is really important to evaluate your product to see if it might be in the scope of these medical device definitions for the regulation of the countries in which you wish to sell the product in.
Is My Product a Medical Device? Read More »
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 »
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 »
Don’t confuse QA and QC in your QMS. Discover the critical differences between Quality Assurance and Quality Control under ISO 13485, and learn how balancing both protects your device and your next audit.
Quality Assurance vs. Quality Control in Medical Devices Read More »
The shift from the In Vitro Diagnostic Directive (IVDD 98/79/EC) to the In Vitro Diagnostic Regulation (IVDR EU 2017/746) represents a fundamental overhaul of how technical files are structured. Under the legacy Directive, manufacturers relied on an Essential Requirements Checklist to demonstrate safety and performance. Under the IVDR, this has been completely replaced by the General Safety and Performance Requirements (GSPRs) found in Annex I.
If you are updating a legacy device technical file or migrating a quality management system, you cannot simply copy and paste your old compliance arguments. The GSPRs require a much higher degree of clinical evidence, lifecycle risk tracking, and technical specificity.
IVD Directive Essential Requirements vs. IVDR GSPR: How to Transition Your Checklist Read More »
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