THE CHALLENGE Missed timelines and EDC build errors compromised the potential success of the company’s phase 1 study.THE SOLUTION Experienced team members and robust internal reviews resulted in a timely, high-quality EDC build and data management plan.THE OUTCOME...
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: 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...
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...
Grounding Your Investment in Human-Centered Design With a Foundational Needs Assessment
We sat down with leaders from top life sciences companies to discuss foundational needs assessments – how to do them, what can go wrong when you don’t, and why every investment decision should start with the question, “What is the need?” “We’ve canceled programs where...
Event Recap: Biocompatibility Insights 2023
This year’s Biocompatibility Insights conference took place in Annapolis, MD, US from September 25–27, 2023. The framework for the event was “Exploring the science behind the regulations” with the sub theme “Addressing challenges in medical device toxicology. Keynote...