In vitro diagnostic (IVD) medical devices

Our team of experts provide support with your quality, regulatory and clinical development strategy, as well as with conducting clinical performance studies and performance evaluations. 

 QA/RA services for IVD medical devices

 Navigating the regulatory landscape is complex. We provide expert consulting services in quality assurance (QA) and regulatory affairs (RA) so that you can move forward with confidence. Our services cover, for example: 

• Regulatory strategy
• Compliance and technical documentation, including classification and conformity assessment
• Performance evaluation
• Market registrations and post market surveillance

IVD medical device CRO services

The purpose of clinical performance studies is to establish or confirm aspects of in vitro diagnostic device performance that cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. The data from clinical performance studies are used in the performance evaluation to demonstrate compliance with the relevant safety and performance requirements with respect to the clinical performance of the in vitro diagnostic medical device.

Our IVD medical device experts can support with all aspects of your clinical performance studies from planning and conducting the study through to analysis and reporting. We also have extensive experience with clinical performance studies and performance evaluations. Our clinical performance study services include:

• Clinical operations, including feasibility assessment and site evaluation, regulatory submissions, and monitoring and site management
• Clinical project management
• Medical writing, including preparation of all necessary documentation
• Data management and biostatistics
• Vigilance
• Outsourcing services to support your team during critical phases when you need extra resources/interim solutions
• Regulatory services