In order to minimize the risks of research, products are developed according to the methods of synchronized R&D at the interface of technology and medicine. Selective partnering with a CRO (contract research organization) may provide the decisive competitive advantage.
The performance requirements of medical products and procedures are constantly increasing. Due to the innovative character of the industry, those companies which focus on research have excellent opportunities to secure market shares with innovative products.
novineon cro supports companies working in the field of medical technology on all matters concerning pre-clinical research, clinical studies, clinical evaluation and certification of products. Due to our proven and documented methods, we have been certified for research on medical products according to ISO 9001. We are audited regularly by the DEKRA Certification Services.
Our service include:
- laboratory testing of prototypes with phantom models, inter alia
- medical evaluation of prototypes parallel to the technical development of new products
- planning and execution of pre-clinical studies and usability tests
- clinical evaluation according to medical product laws and MEDDEV 2.7.1.
- risik analysis
- validation and application-related verification of product characteristics
- development and implementation of effective Post-Marketing Clinical Follow-Up (PMCF) and means of product vigilance
- concept development for clinical testing (including PMCF studies)
- development of testing plans and study documentation
- provision and management of necessary governmental approvals
- selection and training of study centers
- monitoring and auditing
- documentation and data management
- evaluation and reporting of statistics
Regulatory support for non-European markets
- Consulting concerning the different ways of device clearance in the US
- Preparation of submissions for device clearance in the US: Traditional/abbreviated/special 510(k), de novo
- Preparation of Clinical Evaluations by taking into consideration the specific requirements of the notified body in China