The General Safety and Performance Requirements (GSPRs) are detailed in the EU Medical Device Regulations (MDR) EU 2017/745 and detail what a manufacturer must show to prove that the medical devices they sell are safe and perform as intended.
Understanding EU MDR GSPRs Read More »
Electrical safety testing is essential for demonstrating the safety and performance of electrically powered medical devices. This guide explains IEC 60601-1, EMC testing, risk management, applicable standards and the evidence manufacturers need to support regulatory compliance in the UK, EU and other major markets.
Electrical Safety Testing and Validation for Medical Devices Read More »
Understand medical device sterilisation validation, including ISO requirements, sterilisation methods, SAL, bioburden, process validation and routine control.
Medical Device Sterilisation Validation: Methods, Standards & Requirements 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 »
Determining whether your product is a medical device is the first and most important step towards regulatory compliance. This guide explains how regulators assess intended purpose, mode of action and medical claims, helping you understand whether your product falls within the scope of the EU Medical Device Regulation (MDR), the UK Medical Devices Regulations or the IVDR. Whether you’re developing software, wearable technology, wellness products, cosmetics or innovative healthcare solutions, this article will help you identify the correct regulatory pathway and avoid common classification mistakes.
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.
Artificial intelligence is transforming the medical device industry, enabling faster diagnoses, more personalised treatments and smarter connected healthcare. Discover how AI is being used in modern medical devices, the technologies driving innovation and the future of intelligent healthcare.
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 Essential Requirements Checklist: Transitioning to IVDR GSPRs Read More »
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