Capture, manage, and submit regulatory and product data in support of the European Union’s new regulations for bringing medical devices and in-vitro diagnostics to market
Launching a new product is becoming increasingly difficult. As companies expand their presence into multiple countries and markets seeking growth opportunities, this process becomes even more complex. When organizations enter new markets, they need to address new, country-specific regulations. These new rules are ever-changing, making it challenging to adopt them quickly and efficiently. In 2017, the European Union (EU) released a new MDR directive. The guidelines require that companies capture additional regulatory and product information and data. Complying with the regulations mean businesses need to adopt new or modified processes, gather additional business data, and increase business user training to maintain these processes.
Inspirage’s EU MDR solution, built on Oracle Cloud PDH, offers a purpose-driven platform to meet the EU’s MDR guidelines. This solution can be launched quickly and is designed to be compatible with US, EU, and future jurisdiction requirements. Inspirage’s EU MDR solution is integrated seamlessly into an organization’s product launch processes and includes the management of data enriched with UDI business rules. In addition, this solution can be integrated into the EU’s EUDAMED database using Oracle Cloud Product Management (current offering) and Inspirage Global Data Synchronization Network solution (coming soon).
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