Specialized Consulting in the Medical Devices Sector
Global technical, regulatory, and strategic support
At CARJES SOLUCIONES, we have developed our own working methodology through which we integrate ourselves into each client’s organization and become involved in their regulatory and quality objectives from the initial regulatory analysis and strategy to the market launch of products.
Our Experience
Over the past 20 years, we have accumulated experience and knowledge to assist companies in: A strong business strategy is essential for defining the direction of the company and achieving objectives in the most effective way possible. Throughout our professional journey, we have undertaken various comprehensive projects, ranging from regulatory strategy analysis to the design, manufacturing, and market launch of various types of medical devices.
Implementation of Quality Management Systems.
The proper definition and integration of management systems within companies are fundamental for adding value to the company’s management system and serving as a tool for management to identify necessary improvements and make decisions based on real data.
Medical Devices.
The marketing of medical devices requires compliance with legal and regulatory requirements. We develop technical documentation that enables the market launch of medical devices and demonstrates compliance with applicable requirements according to the current requirements of European Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746.
Clinical Studies with Medical Devices.
Clinical studies with medical devices, both pre and post CE marking, are becoming increasingly necessary. As a CRO, our activity involves supporting the study sponsor from study design, obtaining necessary authorizations and permissions, to monitoring and final study report of the medical device.
Training.
Training has always been a fundamental pillar of our activity.
At CARJES, we provide regulatory and technical training on quality management systems tailored to the needs of each company. We also offer courses through training platforms
Auditing.
The success of an audit depends on the people conducting it. Auditors contribute to resource optimization and cost reduction, maximizing the benefits of the audit process and turning it into a true tool for improvement.
Validation of Quality Management Software Systems.
Quality management software systems involved in quality processes have a significant impact on compliance with quality system requirements and product requirements. Therefore, their validation is a key component of the quality management system.
Validation of Quality Management Software Systems.
Quality management software systems involved in quality processes have a significant impact on compliance with quality system requirements and product requirements. Therefore, their validation is a key component of the quality management system.
Mission
The mission of CARJES SOLUCIONES is to develop a methodology that enables the market launch of clients’ medical devices by providing a distinctive style of consultancy based on service, practical solutions, and meeting all clients’ needs.
Vision
The vision of CARJES SOLUCIONES is to fulfill all client requirements, both implicit and explicit, by promoting the integration of quality management system standards, regulatory requirements, and strategy into the daily operations of companies that engage our services.
+34 916 33 51 18
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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.
Experts Professionals
Consultancy specialized in medical devicess, biocides and food and nutritional supplements.
C/ Puerto de los Leones 2, Planta 2. Oficina 12. 28220. Majadahonda. Madrid.
