How to Structure a Medical Device Technical File for EU MDR/IVDR
Technical file (TF) documentation is a structured compilation of documents demonstrating the device meets the regulatory requirements of the EU MDR 2017/745 and EU IVDR 2017/746. The TF must be compiled to meet the requirements of the EU MDR or EU IVDR, and be retained for the device lifetime: at least 10 years after the […]
Risk Management for MDR and IVDR Compliance in 2025
Understand how ISO 14971-based risk management supports MDR and IVDR compliance, from design to post-market surveillance.
FDA QSR vs ISO 13485: The Crucial Differences You Must Know
Navigating the regulatory landscape for medical devices can be complex, especially when comparing US requirements with other international standards. A common question is:
Performance Evaluation Under IVDR: What you Need to Know in 2025
The In Vitro Diagnostic Regulation (IVDR) introduced stricter rules for IVD devices and has fundamentally changed how IVD manufacturers demonstrate the safety and performance of their devices. The requirements for performance evaluation are described within Chapter VI of the IVDR and supported by Annexes I, II, III and XIII. The IVDR, with a special focus […]
How to Manage Risk in SaMD and Avoid Compliance Mistakes
Software as a Medical Device (SaMD) is quickly revolutionising healthcare globally by enabling innovative solutions for diagnosis, treatment, and patient management. Whilst these amazing developments are being made, risk management is critical to ensuring patient safety and compliance with standards (such as ISO 14971) and regulations (such as MDR (EU) 2017/745). It’s critical to have […]
Clinical Investigation 101 for Medical Devices: Importance, Process, and Compliance with EU MDR
Clinical investigations are essential in the development and regulation of medical devices, ensuring their safety, efficacy, and performance. Under the European Medical Device Regulation (MDR) 2017/745, clinical investigations have become more structured and rigorous, requiring thorough planning, precise execution, and compliance with regulatory frameworks. In this blog, we’ll explore what clinical investigations entail, why they […]