In today’s reality, new products have to comply with a multitude of different regulations and it becomes difficult to keep up with the current status.
The variety of requirements worldwide is increasingly complex. Therefore, the regulatory pathway often becomes as time- and cost consuming as the development of the product itself.
The experience and even capacity of regulatory departments can allow them to become gate keepers to successful market entrance for new devices.
CeramTec has recognized that additional regulatory support is becoming increasingly important for our customers in return for driving innovation. Our experience working with regulatory bodies on a worldwide basis enables us to offer a wide range of regulatory services for the key markets of Europe and the United States, along with additional selected international geographies. Because our Regulatory Affairs team is based on two continents – one part in Germany and the second part in the US – we are positioned to closely collaborate with our US customers and the FDA.
Our services include customized projects and regulatory pathway planning, device classification and evaluation of predicate devices, technical file preparation and submission, as well as negotiations and communication with the responsible national authorities.
Even after successful approval, we offer ongoing regulatory services, e.g. support of change notifications and renewals.
- Professional regulatory competence and detailed experience, enabled by a small and highly specialized cross-functional team
- Up-to-date knowledge of changing global regulations, ensured through continuous exchange with authorities and notified bodies
- Proven quality of support provided to customers, confirmed during reviews by authorities worldwide
- Efficient communication channels, based on our one-stop-shop philosophy
- Reduced time-to-market, by taking advantage of our services from the start of product development activities