U.S. Food and Drug Administration
Whether 510(k), De Novo, or PMA: We support you on your way into the US market.
International Regulatory Affairs – FDA and Health Canada
Your Presence on the International Stage
The path of your medical device into various national markets typically passes established milestones: design validation, risk management, post-market surveillance, labeling… But the devil is in the details. Even if the requirements prior to market approval may seem similar, even internationally recognized concepts can have a local flavor. One example is risk classification: although categorizing medical devices by risk is a widely used approach, the groups and their gradations vary between countries. novineon CRO discusses with you the approach to other markets and highlights where differences and similarities exist.
novineon CRO helps you develop a strategy to effectively meet the requirements of different countries while leveraging synergies.
The core focus of our work is on FDA approvals (510(k), De Novo, PMA) and Canadian Medical Device Licence Applications to Health Canada – for both medical devices and in vitro diagnostics (IVDs).
Service Portfolio
Our service portfolio covers the following:
- Requirements and Knowledge Transfer: In a workshop format, we discuss the specific characteristics of target markets, present requirements, and jointly develop how these can be implemented for your products.
- Submission Preparation: Building on existing documentation and taking national requirements into account, we compile the submission. In addition to product-specific content, several formal aspects must also be considered.
- Submission Support: Medical devices and their applications often require explanation. Therefore, follow-up questions from the review of a submission are not uncommon. Here, it is important to understand what the reviewing authority considers important.
