Ivan Vecerina Conseils

Bringing Medical Device Technologies to Market

Active in the design, development, and validation of medical devices since 1995, our expertise is centered on medical software and devices, where increasingly stringent validation and safety requirements are to be met.

We provide a uniquely integrated know-how at the junction of clinical, technology, and regulatory challenges, with the following areas of expertise:

Projects Management of medical technology projects, especially for software-driven technologies. Our cross-functional expertise is especially useful in planning stages, when we can accelerate your development and avoid expensive mistakes.
IEC 62304 Effective development and validation methodologies for the complete software lifecycle
IEC 62366 Human Factor and Usability Engineering, for compliance with current FDA and international requirements.
ISO 13485 Implementation of certified Quality Management Systems for manufacturers and suppliers
ISO 14971 Risk management applied to the development, design, manufacture, and distribution of medical devices
ISO 14882 C/C++ and embedded development expertise, team mentoring and secure software development (embedded, imaging, robotics)
CE Mark,
FDA
Complete services, from company certification, dossier approval, and post-market surveillance
Vigilance EU Authorized Representative role, and world wide complaint review and vigilance services
Automation Validation of software used in automated manufacturing, clinical data capture, and quality processes in general

Our activities are supported by a global network of partners, which complete our expertise in areas such as Human Factors, submission to FDA and other key markets, or global sales and distribution.

Contact us first by email with any question or inquiry; within 24 hours, our team will provide an assessment, and when appropriate make a proposal to help you accelerate your market entry, and secure your growth.

   -- Dr med Ivan Vecerina