Near-patient testing (NPT) devices face substantial challenges under the new IVDR, including: New Stringent Regulatory Constraints due to IVDR Risk-Based Approach for Usability and Human Factors, including Use Environment Expectations from Notified Bodies In this...
Webinar – 2024 IVDR Sprint Series: How to Deal with Regulatory Requirements when Collecting Clinical Performance Data
Mastering Time and Compliance How to Deal with Regulatory Requirements when Collecting Clinical Performance Data IVDR imposes stricter requirements for clinical evidence, including a higher level of scrutiny and more stringent criteria for study design,...
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: The Impact of the Cleaning Process on Sterilization Validation and Biocompatibility Activities
The Impact of the Cleaning Process on Sterilization Validation and Biocompatibility Activities The achievement of a suitable level of cleanliness in the manufacturing of medical devices is an indispensable precondition to providing patients, users and...
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...
Bridging Design and Manufacturing
For growth-stage companies, finding a contract manufacturer to take on low volume runs and bridge the gap between design and manufacturing can be a challenge. Especially where time and cashflow is concerned, it’s critical to work with a partner that can seamlessly...
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...