The EU Commission recently published (January 23, 2024) a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring availability of safe devices that are essential for healthcare systems. With this...
2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of the device's risk class (Yes, even class A devices require a proper performance evaluation!). As...
Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule
On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System Regulation (QSR). The final rule is effective February 2, 2026. The FDA plays a crucial...
Webinar: 2024 IVDR Sprint – How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines
2024 IVDR Sprint How to Adopt a Proactive Approach to Ensure Timely Compliance with the Applicable Deadlines The In-Vitro Diagnostic (IVD) industry plays a pivotal role in modern healthcare by providing crucial information for patient management. In Europe, the...
Webinar – 2024 IVDR Sprint Series: The Clinical Challenge – Addressing Increased Evidence Requirements in the EU IVDR Era
The Clinical Challenge Addressing Increased Evidence Requirements in the EU IVDR Era In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of...
Webinar: Introduction to ISO/IEC 27001 – Information Security Management Systems
Introduction to ISO/IEC 27001 - Information Security Management Systems A key component to protect your data Information security is a critical field dedicated to safeguarding an organization's digital assets, data, and information systems from unauthorized...
Webinar: Regulatory Strategy for New Neurological Medical Devices
Regulatory Strategy for New Neurological Medical Devices Considerations for an effective balance between non-clinical and pre-clinical evaluations Regulatory considerations and preclinical aspects are major parts of getting any medical device to market. Finding...
Webinar: Medical Devices Incorporating or Generating Nanomaterials
Medical Devices Incorporating or Generating Nanomaterials What manufacturers should consider to ensure safety and biocompatibility The concept of nanomaterials and their possible applications was first introduced by Richard Feynman, which earned him the...
Nanomaterials in Medical Devices: Biological Risks and Methodology for Biocompatibility Assessment
Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our lives. Among these, medical devices stand as a promising frontier. The unique properties of nanomaterials, stemming from...
Biocompatibility of Medical Devices: Process, Detailed Steps and 7 Hot Topics to Crack the Code of Medical Device Safety
The landscape of modern healthcare has been completely transformed by the development of cutting-edge medical devices. From life-saving implants to innovative surgical tools, these medical devices have become indispensable in healthcare. However, behind every...