REGULATORY SUBMISSIONS

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.

510(K) SUBMISSIONS

A 510(k) submission is required unless the device is exempt from 510(k) requirements or if the device is classified as Class III. 

PMA SUBMISSIONS

Premarket approval (PMA) is the FDA process to evaluate the safety and effectiveness of Class III medical devices.

IDE SUBMISSIONS

An investigational device exemption (IDE) allows the investigational device to be used in clinical studies in order to collect safety and effectiveness data. 

FDA PRE-SUBMISSIONS

The US FDA strongly recommends a Pre-Submission process to request feedback on PMA applications, HDE applications, de novo petitions, and 510(k) Submissions

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.

INTERNATIONAL REGISTRATIONS

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.