Clinical data on your Medical device is key to the transition from the Medical Device Directive to the Medical Device Regulation. Your Clinical Trials will be vital in obtaining and/or maintaining the CE-mark.
A common mistake when selecting a partner for Clinical Evaluations and Clinical Investigations is to turn to a large pharma focused CRO for guidance.
We are a full-service Clinical Development partner with Project Leaders, CRAs, CTAs, Statisticians, Data Managers, Regulatory Managers, Medical Advisors and Medical Writers employed by Symbioteq, with the unique feature of expertise in Medical Device Regulatory and Quality compliance. We can support you both on a local and global scale through a tight network of Medical Device professionals.
If you need the full-service concept then we can do that or if you only need biometrics, monitoring or medical writing for instance then that is also something we can support you with.
Another big difference is that we do not give you a budget with a lot of air or send you out of scope invoices. We bill for the work we do, and we can easily integrate with your own staff.
Send us a mail or give us a call to start your clinical development! Or why not ask for a Gap analysis?
We have the attitude and knowledge your medical device needs!
We aim to be different!
o 100% focused Medical Device Clinical Development Partner in Northern Europe
o Flexible and adaptable to Your needs, working as part of Your team
o Experience from (very) small, medium and large manufacturers
o Ensure the correct and justified Clinical Development plan harmonized with Regulatory and QMS requirements
o We know how to handle device pre- and post-market and, in all risk-classes