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:
|IEC 62304||Development and validation methodologies for the complete software lifecycle|
|ISO 13485||Implementation of certified Quality Management Systems for manufacturers and suppliers|
|ISO 14971||Risk management applied to the design, manufacture, and distribution of medical devices|
|ISO 14882||C++ development, team mentoring and secure software development (embedded, imaging, robotics)|
|Projects||Management of medical technology projects, especially for software-driven technologies|
|CE Mark||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 with any question or inquiry; our team will review how we can accelerate your market entry and secure your growth.
-- Dr med Ivan Vecerina