Big regulatory changes are coming to the way medical device companies sell their products in the European Union (EU). Previous product management strategies are becoming antiquated and exponentially increasing risk.
As a part of the changes in the EU, Unique Device Identification (UDI) and Basic UDI will be a requirement for medical devices. The new regulatory initiative falls under the EU Medical Device Regulation (MDR) and supersedes the Medical Device Directive (MDD), which previously had no provisions on traceability of medical devices, so the steps necessary for compliance are completely new for organizations selling products in the EU market.
As deadlines to comply quickly approach in May 2020, we can help you take charge of your regulatory compliance strategy and plan for the new medical device regulatory climate.
Kalypso’s hands-on EU MDR experience helps global medical device organizations achieve their compliance goals and deadlines.
The three-phase approach is designed to drive maximum value with an iterative crawl-walk-run cycle.
At Kalypso, our sweet spot is structuring a consolidated PLM system as the product quality and compliance backbone in support of some key EU MDR work streams:
Kalypso and leading life sciences companies are combining the best of both worlds to deliver world-class software implementation and validation support.
Our strategic software partners provide strategy and compliant technology solutions to regulated life sciences companies and make it easy to accelerate transformation and innovation. They focus exclusively on the regulated biotechnology, pharmaceutical and medical device industries and are compliance partners with the world’s top technology platforms and applications.