anteris medical’s expertise contributed to the Medical Device registration at FDA
anteris accompanies an aspiring company in pre-submission preparations for a highly innovative product.
In the role as regulatory affairs manager, anteris consultants support the product definition and regulatory positioning. We support the clarification process with regulatory by preparation of registration documents. In determining the indications of use, the most suitable predicate device was carved out. Furthermore, anteris medical coordinates the exchange with the US agent.
We are highly experienced in finding and defining the best regulatory positioning.
- 510(k) pre-sub
- Regulatory positioning
- Highly innovative product
- Product definition
- Predicate device
- Innovative product
- Innovative registration strategy
- Identification of predicate devices in line with product development strategy
- Consultation to find the ideal submission pathway
- Support of any FDA interaction including preparation and execution of FDA pre submission meetings