In this recorded webinar, learn some of our first-hand industry expertise, helping you stay attuned to the latest industry developments, challenges and advancements specifically related to Companion Diagnostics and IVDs.

In this recorded webinar, acquire insights into the In Vitro Diagnostic Regulation (IVDR) landscape, and comprehend how IVDR requirements aid organizations in fulfilling legal and regulatory obligations associated with In Vitro Diagnostics (IVD) compliance in the EU market.

In this recorded webinar, gain an in-depth comprehension of IVDR requirements relevant to Performance Evaluation, and understand the importance and benefits of conducting a Performance Evaluation as early as possible in the design and development of a new IVD, or in preparation for the transition of a legacy device to IVDR.

In this recorded webinar, gain an understanding of the clinical performance study prerequisites outlined in the In Vitro Diagnostic Regulation (IVDR), improve comprehension of utilizing EN ISO 20916:2024 to ensure clinical performance studies align with IVDR compliance standards and learn best practices and pitfalls to avoid during the preparation and execution of a clinical performance study, drawn from our expertise as CRO requirements.

To expedite the Technical Documentation review process by the Notified Body and avoid extra costs and delays (which potentially could make your company miss the May 2024 deadline), your technical documentation submission needs to be right the first time!

Medical Device Software (MDSW) is a growing, fast-evolving industry. The purpose of this article is to address some of the most common (and not always right) assumptions and provide useful and truthful information about the process of reaching the conformity assessment under MDR, for successfully placing an MDSW on the market.

It is never too early in your project to start planning for sample size selection, considering its impact on your timelines, the cost of tests or the quality and quantity of representative devices to be produced to that end.