Quality system for medical device trials
In Europe, clinical trials with medical devices must be conducted according to the ISO14155 standard. According to this standard, the sponsor should have a set of procedures in place to ensure the clinical trial is being conducted per protocol, local law and the ISO14155 standard. Common Sense Clinical offers a lean and flexible quality system to meet your various clinical needs. Furthermore, the system is informative and practical so it can be used as a guide through all the phases of your trial, no more re-inventing the wheel! Besides procedures, the system contains all templates and forms needed to run your trial successfully.
The quality system can be accessed through an online portal, accessible with any device, so the documents are always close at hand.
When purchasing an annual license (per clinical trial, per year), multiple accounts can be created ensuring everyone in the clinical team has access to the system.
Please send an email or call for a demo and/or more information.
Benefits quality system
User friendly
Highly flexible and usable system that fits every situation within the existing QMS. Unlimited accounts per license/study.
Includes all forms and templates.
Informative procedures
Step by step guidance throughout the study proces. An extensive onsite training is included in the first annual license.
Cost efficient
No need to hire an expensive CRO. Keep control of the budget, only contract the required expertise.
Licenses can be purchased annually.