CROMSOURCE provides accurate and real-time safety management of global medical device studies in all phases of development, pre- and post-market. Our expert Materiovigilance team is in constant and direct communication with physicians, CRAs, regulatory authorities, and the client to ensure full control at every stage of the project. The CROMSOURCE medical teams are also experienced, certified users of EudraVigilance.
CROMSOURCE is experienced in addressing the disparate safety reporting requirements in different EU countries and the US Our experts are strategically based in different time zones across North America and Europe to ensure uninterrupted services.
Our medical monitors are available 24/7 in all time zones in order to address any safety issues as they arise.
Safety reports are managed proactively so that the sponsor and investigator teams are fully invested in any safety decisions made or expedited reports submitted. Experienced CROMSOURCE medical staff will interface with regulatory authorities (including the FDA) and sponsors to ensure that any safety issues that arise are managed efficiently and pragmatically.
- Changes to EU Medical Device Legislation: What you need to know - White Paper June 2016
- Clinical Data for Medical Devices - Preparing for increased requirements in the EU - White Paper, 2015
- Medical Device Overview
- Clinical Evaluation Reports - White Paper, 2015
- Wound Closure - White Paper, 2014
- EU Recast of the Medical Device Directives: The Rocky Road to the new Medical Device Regulation - White Paper, 2014
- Language Requirements for EU Medical Device Labels - Multilingual, September 2012