We provide up-to-date, innovative and customized support for medical devices.
Our support is provided through the development, registration and maintenance of medical devices and combination products. Our support ranges from regulatory strategy and advice on development, up to product registration and post-marketing activities.
Our team has long-standing experience in many therapeutic areas and product classes.
| Development phase | Registration phase | Maintenance phase |
| Classification of products
Identification of conformity assessment procedure |
Technical & design dossier | Full lifecycle management |
| Setting up QMS
Identification of applicable standards |
Clinical evaluation reports | Scientific literature search |
| Defining regulatory, biocompatibility and clinical strategy | Creation of risk management process | Device vigilance |
| Usability (human factor) studies | Liaison with competent authorities and notified bodies | Maintenance of risk management report |
| Change control management | Answering list of questions | Post-market clinical follow up |
| Identification of equivalent devices | Full registration support and CE-marking | Vendor audits/preparation of annual audit |