Vecerina Medical Advance
Bringing Medical Device Technologies to Market
Active in the design, development, and validation of medical devices since 1995, we have led the validation, clinical and regulatory approvals, and launch of a range of devices, in particular solutions involving software (robotics, calrdiovascular). Our expertise is centered on medical software and devices, when 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:
| Evaluations | Conduct of audits (internal, suppliers) or regulatory evaluations for due diligence assessments. |
| Clinical | Design and definition of clinical studies (IB, CIP, CRF), Clinical Evaluations, and approvals by authorities (Europe). |
| CE Mark, FDA |
Strategic guidance or direct support for your MDR approvals or FDA submissions, including determination of approval pathway, and conduct of meetings with regulators when needed. |
| Projects | Management of medical technology projects, especially for software-driven technologies. We help implement lean and agile methods that can accelerate product development while satisfying regulatory requirements. |
| Usability | Evaluation of device designs, planning and conduct of Usability Engineering studies (home use devices, complex software systems) in compliance with FDA and EN IEC 62366 requirements. |
| QMS Compliance | Implementation of Quality Management Systems (ISO 13485), optimization or harmonization of processes across sites. |
| ISO 14971 | Risk management applied to the development, design, manufacture, and distribution of medical devices |
| Vigilance | EU Authorized Representative role or consulting Person Responsible for Regulatory Compliance (MDR PRRC), 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 authorities in Asia, or global sales and distribution.
Contact us first by email with any question or inquiry; we usually provide feedback within 24 hours, and strive to show you ways to accelerate product development, clinical evaluations, and market access.
-- Dr med Ivan Vecerina