When Should You Involve a CRO in Medical Device Development?
The optimal time to engage a Contract Research Organization (CRO) in your medical device’s development is as early as possible, ideally during the initial planning phase of your clinical study. Involving a CRO from the outset ensures a study design that is robust and compliant with regulatory standards, such as MDR 2017/745 and IVDR 2017/746, helping you avoid unexpected delays and costs. Here’s why early involvement is essential:
Regulatory Expertise: CROs provide specialized regulatory knowledge, guiding you through compliance with critical standards like ISO 14155 for medical devices and ISO 20916:2019 for in vitro diagnostic devices. This ensures that your study meets all necessary requirements, minimizing risks of non-compliance.
Study Design Optimization: With CRO expertise, you’ll have a well-defined, compliant study tailored to data collection, patient recruitment, and efficient study management, facilitating successful clinical evaluations and comprehensive data management for clinical trials.
Cost and Time Efficiency: Planning alongside a CRO from the start helps reduce costs and prevent delays from later adjustments, ensuring optimal resource use from day one.
Want to ensure a smooth development path for your device? Discover how collaboration with a CRO can optimize every phase of your project, from regulatory alignment to MDR and IVDR compliance for clinical trials in the European market.
We remind you that we’ll be present at MEDICA 2024!
From November 11 to 14 in Düsseldorf, visit us at our stand Hall 6 / G62. This is the perfect opportunity to talk to us directly and discover how we can support you at every stage of your medical device development journey. We look forward to meeting you!
