AltaQ helps medical device and in-vitro diagnostics companies to implement effective regulatory strategies to complete regulatory projects covering IDE, 510(k), de novo 510k and PMA. Our team members have successfully led projects from FDA pre-submissions through achieving clearances and approvals. We incorporated project management techniques to develop and monitor regulatory plans to achieve regulatory milestones.
An investigational device exemption (IDE) allows the investigational device to be used in clinical studies in order to collect safety and effectiveness data.
CE MARKING SERVICES
CE marking is the medical device or in-vitro diagnostics manufacturer's claim that a product meets the essential requirements of all relevant EU Directives.
In addition to providing support for US and EU markets, AltaQ helps manufacturers to register their products in multiple countries as part of their commercialization plans.