Specialized Health Consultancy
Global technical, regulatory and strategic support
We will provide the support you need for the design of the regulatory strategy, implementation of quality management system, training, and technical documentation elaboration to meet the applicable regulatory requirements.
Regulatory and technical support to get the CE marking and to meet the compliance with marketing requirements in the European Union.
Quality management system:
We develop and implement quality management systems in accordance with ISO standards and FDA requirements.
Surface disinfectants in the healthcare environment and antiseptics for healthy skin.
Food and nutritional supplements:
Elaboration and preparing the submissions of dossier for the authorization of food and nutritional supplements for medical use.
Helping companies manufacturing ocular “Medical Devices” to accomplish MDR.
The entry into force of the MDR (Medical Device Regulation) poses a series of challenges for companies if they intend to maintain the “CE” marking on their products or to introduce new ones into the European market.
Issues such as the mandatory preclinical and clinical studies, critical reviews of the literature, trend and safety reports, in many cases require the participation of researchers who not only have experience in this field, but also have significant clinical experience.
Aware of this, an alliance has been established between Vision R&D, linked to the University of Valladolid, OcuPharm Diagnostics, linked to the Complutense University of Madrid, and Carjes Soluciones, Specialized Consulting in the health sector, to help companies in a wide variety of aspects ranging from regulatory to preclinical tests and clinical studies adapted to the product and to the needs of the companies.
The vast experience of these three companies, with a high clinical and investigative component completely focused on eye medical devices, makes it possible to propose and execute solutions allowing companies to comply with the regulations contained in the MDR.
Do you need advice?
We help you in everything you need develop a work plan with your company.
How may we help you?
Our experience is always at the service of our clients and their needs.
Consultancy specialized in medical devicess, biocides and food and nutritional supplements.
C/ Gran Vía 33 , Planta 2- Oficina 4. 28220. Majadahonda. Madrid.