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: 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: 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...
Webinar: Precision Medicine and Alzheimer’s Disease: Overcoming Biomarker Testing Barriers for Alzheimer’s Disease Patients
Tuesday, October 03, 2023 | 12pm EDT / 11am CDT / 9am PDT / 5pm BST (UK) / 6pm CEST (EU-Central) Advances in biomarker testing are revolutionizing strategies for diagnosing and managing neurological disorders and shifting the current treatment paradigm to a more...
Webinar: Medical Technology – The Innovation Imperative for Growth Stage Companies
In this webinar, featured speaker Brandon Bogdalek will interview three panelists in medical technology space. The panelists will discuss the innate need to innovate as a growth stage company, and the different strategies used to bring differentiated products to...
Webinar: Digital Health – Embracing Human-Centered-Design to Create Impactful Digital Experiences
In this webinar, featured speaker Brandon Bogdalek will interview Greg Silvesti from Sage Therapeutics. Brandon and Greg will discuss how to use human-centered design principles and techniques to create digital experiences that patients love. In a world where digital...
Webinar: Point-of-Care Diagnostics – Best Practices for Bringing Novel Solutions to Market
In this webinar, featured speaker Brandon Bogdalek will interview three industry leading panelists in the diagnostics industry. The panelists will discuss best practices for bringing novel point-of-care diagnostic solutions to market. The audience will hear from...